This is the current release of the guideline.

Prostate cancer

Men with a histological or clinical diagnosis in accordance with a primary prostate adenocarcinoma

Note: This guideline is not designed for asymptomatic men with elevated levels of prostate-specific antigen (PSA) without a histopathological diagnosis of prostate cancer, nor for patients with metastasis in the prostate from other tumours, nor for children and adults with other malignant tumours in the prostate, both epithelial and non-epithelial, such as the cell carcinoma and rhabdomyosarcoma.

Evaluation

Classification of prostate cancer

• Tumour-node-metastasis (TNM) classification
• Histopathological grading
• Classification according to the clinical or pathological stage
• Classification according to risk

Management/Treatment

1. Localized prostate cancer
   • Initial choice of treatment
   • Surgery
   • Radiotherapy
   • Hormone therapy
   • Monitoring
2. Locally advanced prostate cancer
   • Initial choice of treatment
   • Adjuvant radiotherapy
   • Lymphadenectomy
   • Adjuvant/neoadjuvant hormone therapy
3. Prostate cancer in prostate specific antigen (PSA) relapse
   • Definition of PSA relapse
   • Salvage treatment after surgery
   • Salvage treatment after radiotherapy
   • Hormone therapy
   • Intermittent vs continuous hormone therapy
4. Disseminated prostate cancer
   • Hormone therapy
   • Chemotherapy
   • Bisphosphonates and radiopharmaceuticals

Bibliographic Search in: The Cochrane Library, Database of Abstracts of Review of Effectiveness (DARE), Medline-PubMed, Embase, Trip Database, Indice Medico Espanol (IME) and manual search. Languages of studies elected: English, French, Italian, Portuguese, and Spanish. A preliminary search of clinical practice guidelines (CPGs) was carried out to get the bibliography used in the "Clinical Practical Guideline for Prostate Cancer Treatment". Two CPGs on prostate cancer were identified and rated with the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument. With the results of the evaluation, one of them was chosen as a secondary source of evidence to help with specific sections in the guideline, according to the elaboration, adaptation and updating methodology used in the Basque Country clinical practical guideline on asthma.

A search of systematic reviews was also carried out for each one of the guideline questions. An extended search of original studies was carried out, for all those questions unable to be answered with the previously selected CPG or the reviews found. The search initially focused on randomized controlled trials, although other types of original studies (observational studies, prognostic studies, case series) were searched when it was necessary.

Detailed information on the search strategies for each question in Medline (PubMed) and Embase are in the appendix of the companion document Bibliographic Search Methodology. (See the "Availability of Companion Documents" field.)

Not stated

Levels of Evidence

1++ - High quality meta-analyses, systematic reviews of clinical trials or high quality clinical trials with a very low risk of bias.

1+ - Well-conducted meta-analyses, systematic reviews of clinical trials or well-conducted clinical trials with a low risk of bias.

1- - Meta-analyses, systematic reviews of clinical trials or clinical trials with a high risk of bias.

2++ - High quality systematic reviews of case control or cohort studies. High quality case control or cohort studies with very low risk of bias and a high probability of establishing a causal relationship.

2+ - Well-conducted case control or cohort studies with a low risk of bias and a moderate probability of establishing a causal relationship.

2- - Case control or cohort studies with a high risk of bias and a significant risk that the relationship is not causal.

3 - Non-analytical studies, e.g., case reports and case series.

4 - Expert opinion.

Note: Studies classified as 1- and 2- should not be used in the process of developing recommendations due to their high possibility of bias.

The quality of the studies and a summary of the evidence for each question were evaluated following the Scottish Intercollegiate Guidelines Network (SIGN) recommendations. (See the "Rating Scheme for the Strength of the Evidence" field.)

The methodology employed is included in the following document: "Preparation of Clinical Practice Guidelines in the National Health System: Methodology Manual," from the Ministry of Health and Consumer Affairs and the Aragon Institute of Health Science.

The steps to be followed were:

• Forming the guidelines preparation group, composed of specialists in urology, radiotherapy, medical oncology and pathology, nursing in urology and methodologists.
• Formulation of clinical questions using the format: Patient/intervention/comparison/outcome or PICO.
• Bibliographic Search (see the "Description of Methods Used to Collect/Select the Evidence" field).
• Evaluating the quality of the studies (see the "Description of the Methods Used to Analyze the Evidence" field).
• Preparing recommendations based on "formal evaluation" or "reasoned judgment" in Scottish Intercollegiate Guidelines Network (SIGN). The classification of evidence and the grading of the recommendations was done with the SIGN system (see the "Major Recommendations" field). Controversial recommendations or those with an absence of evidence were resolved by consensus during several meetings of the preparation group.
• Expert collaborators participated in the revision and drafting of the recommendations.
• Collaboration from the following scientific organizations was received: the Spanish Association of Urology (AEU), Spanish Society of Radiotherapeutic Oncology (SEOR), Spanish Society of Medical Oncology (SEOM) and the Spanish Association of Nursing in Urology (AEEU), who were represented by members of the preparation group, the expert collaborators and the external reviewers.

Additional information regarding the Clinical Practice Guideline (CPG) methodological process is available at http://www.guiasalud.es .

Grades of Recommendation

A: At least one meta-analysis, systematic review or clinical trial rated as 1++, which is directly applicable to the target population of the guideline; or a body of evidence consisting mainly of studies rated as 1+, which demonstrate overall consistency of results.

B: A body of evidence consisting mainly of studies rated as 2++, directly applicable to the target population of the guideline, which demonstrate overall consistency of results; or evidence extrapolated from studies rated as 1++ or 1+.

C: A body of evidence consisting of studies classified as 2+, directly applicable to the target population of the guideline, which demonstrate overall consistency of results; or evidence extrapolated from studies rated as 2++.

D: Evidence level 3 or 4; or extrapolated evidence from studies rated as 2+.

Good Clinical Practice (GCP)*: Recommended practice based on clinical experience and the consensus of the development group.

*Sometimes the development group was aware of some important practical aspect which needed to be emphasized but for which there was probably no evidence to support it. Generally, these cases were related to some aspect of the treatment considered as good clinical practice which nobody would normally question. These aspects were evaluated as good clinical practice points. These messages are not an alternative to recommendations based on the evidence, but must be considered only when there is no other way to highlight this aspect.

Two publications agree in concluding that delayed hormone therapy (HT) is more cost-effective than the immediate treatment in patients with advanced prostate cancer.

Expert collaborators participated in the revision and drafting of the recommendations and the external reviewers supplied notable contributions to the draft guidelines revision.

Collaboration from the following scientific organizations was received: the Spanish Association of Urology (AEU), Spanish Society of Radiotherapeutic Oncology (SEOR), Spanish Society of Medical Oncology (SEOM) and the Spanish Association of Nursing in Urology (AEEU), who were represented by members of the preparation group, the expert collaborators and the external reviewers.

Levels of evidence (1++ to 4) and grades of recommendation (A to D, and GCP) are defined at the end of the "Major Recommendations" field.

Localized Prostate Cancer

Initial Choice of Treatment

Question to Answer: For patients with clinically localized prostate cancer, what is the safety and efficacy of different treatment options?

B - In patients with clinically localized prostate cancer with a life expectancy exceeding 10 years, radical prostatectomy or external beam radiotherapy is recommended.

A - In patients with clinically localized prostate cancer treated with external beam radiotherapy, it must be 3-dimensional conformal, as this allows the administration of higher doses of radiation with greater safety.

D - In patients with clinically localized prostate cancer treated with external beam radiation, brachytherapy may be associated to allow escalating dosages to be achieved.

D - In patients with clinically localized prostate cancer at low risk (cT1-cT2a, Gleason <7 and prostate specific antigen (PSA) ≤10 ng/ml), low or high dose brachytherapy as a monotherapy is an alternative treatment with intent to cure for prostate volumes less than 50 cm³.

B - In patients with clinically localized prostate cancer with a life expectancy below 10 years, watchful waiting may be an alternative.

D - In patients with clinically localized prostate cancer at low risk, Gleason <3 + 3, <50% affected cylinders in the biopsy and PSA <15 ng/ml, active surveillance can be offered as an alternative to immediate radical treatment.

GCP - Monitoring of patients with active surveillance will be as follows:

• PSA determinations and rectal examination every three months during the first 2 years, then later, every six months.
• Prostate biopsy at 1 year, at 4, and at 7 years (there must be at least 10 cylinders per biopsy).

GCP - In patients with active surveillance, radical treatment will be considered when any of the following data appear: PSA velocity >1 ng/ml/year, higher degree or greater extension of the tumor in repeated biopsies, or evidence of locally advanced disease in a rectal examination.

A - Primary cryotherapy and high intensity focused ultrasound techniques are experimental in prostate cancer patients at a clinically localized stage.

Surgery

Questions to Answer

• In patients with clinically localized prostate cancer for which surgery is indicated, what is the safety and efficacy of different types of laparoscopic radical surgery (transperitoneal or extraperitoneal, robot-assisted or not) in comparison with open radical prostatectomy?
• In a patient with clinically localized prostate cancer for which radical surgery with intent to cure is indicated, does lymphadenectomy increases cure rates for the disease? And which is better, extended or limited lymphadenectomy?
• In patients with clinically localized prostate cancer for which radical prostatectomy is indicated, what percentage of positive surgical margins are obtained when keeping or not keeping neurovascular bundles (uni- or bilaterally)? And what results are obtained with regard to urinary incontinence and erectile dysfunction?

B - In clinically localized prostate cancer with radical prostatectomy indicated, either laparoscopic or open surgery can be employed.

C - In patients with clinically localized prostate cancer at low risk (cT1-cT2a and Gleason <7 and PSA ≤10 ng/ml), lymphadenectomy is not necessary when performing radical prostatectomy.

D - In patients with clinically localized prostate cancer risk at intermediate or high risk treated with radical prostatectomy, a lymphadenectomy must be performed.

D - In patients with clinically localized prostate cancer with radical prostatectomy indicated, it is recommended to preserve the neurovascular bundles when intraoperative findings permit.

Radiotherapy

Question to Answer: In patients with clinically localized or locally advanced prostate cancer for which radiotherapy is indicated (external and/or brachytherapy), what volume, dose and fractionation have the best safety and efficacy depending on the risk?

B - In patients with clinically localized prostate cancer at low risk (cT1-cT2a and Gleason <7 and PSA ≤10 ng/ml), the dose of external beam radiation should be 72-74 Gy.

B - In patients with clinically localized prostate cancer at intermediate risk [cT2b or Gleason = 7 or (PSA >10 and ≤20 ng/ml)], the dose of external beam radiation should be 76-78 Gy.

B - In patients with clinically localized prostate cancer at high risk (T2c or PSA >20 ng/ml or Gleason >7) or with prostate cancer at the locally advanced clinical stage (cT3), the dose of external beam radiation must be at least 78 Gy.

B - In patients with localized prostate cancer at low risk, only the prostate must be radiated.

C - In patients with prostate cancer and a ≥15% risk of lymph node invasion, radiation of the prostate and seminal vesicles is recommended.

Hormone Therapy

Question to Answer: In patients with clinically localized prostate cancer subjected to treatment with intent to cure, does the implementation of neoadjuvant or adjuvant hormone treatment improve cure rates for the disease?

A - In patients with clinically localized prostate cancer at low risk (cT1-cT2a and Gleason <7 and PSA ≤10 ng/ml) or intermediate risk [cT2b or Gleason = 7 or (PSA >10 and ≤20 ng/ml)], neoadjuvant hormone therapy with radical prostatectomy should be avoided.

B - In patients with clinically localized prostate cancer at low or intermediate risk, hormone therapy adjuvant to radical prostatectomy should be avoided.

A - In patients with clinically localized prostate cancer at low risk, neoadjuvant hormone therapy with radiotherapy should be avoided.

B - In patients with clinically localized prostate cancer at low risk, hormone therapy adjuvant to radiotherapy should be avoided.

GCP - In patients with clinically localized prostate cancer at intermediate risk, the use of neoadjuvant or concomitant hormone therapy to radiotherapy is recommended.

GCP - In patients with clinically localized prostate cancer at high risk (cT2c or PSA >20 ng/ml or Gleason >7), the criteria used in the patient with locally advanced prostate cancer will be followed for the use of neoadjuvant or adjuvant hormone therapy to radical prostatectomy or radiotherapy.

Monitoring

Question to Answer: When can the monitoring of a patient with localized prostate cancer after treatment with intent to cure (radical prostatectomy and radical radiotherapy) be completed? What tests should be performed, and how often?

D - The unusual case of a Gleason score of 2-4 being found in the prostatectomy sample should be viewed with caution until reviewed by another expert.

D - Patients with a confirmed Gleason score of 2-4 in the prostatectomy sample do not require monitoring for cancer.

D - Patients with prostate cancer in clinical stages T1a who have undergone radical prostatectomy do not require monitoring for cancer.

D - Prostate cancer patients in clinical stages T1b-T1c who have undergone radical prostatectomy require monitoring within 10 years.

D - For the rest of the patients with clinically localized prostate cancer (T2) after treatment with radical prostatectomy, the monitoring period should be 15 years.

D - The minimum period of monitoring for patients with clinically localized prostate cancer after radiotherapy with intent to cure should be 8 years.

D - The only monitoring for patients with clinically localized prostate cancer treated with radical prostatectomy or radiotherapy are PSA controls, providing biochemical progression is not detected.

D - The recommended PSA monitoring frequency for patients with clinically localized prostate cancer is 3, 6 and 12 months after treatment with intent to cure, then every 6 months after the 1st year, and annually after the third year.

Locally Advanced Prostate Cancer

Initial Choice of Treatment

Question to Answer: What is the safest and most effective treatment for a patient with prostate cancer at the locally advanced clinical stage?

GCP - In patients with prostate cancer at the locally advanced clinical stage with a life expectancy exceeding 10 years, treatment with 3-dimensional conformal radiotherapy or conformal radiotherapy + brachytherapy is recommended.

D - In patients with prostate cancer at the locally advanced clinical stage who require radiotherapy treatment, 3-dimensional conformal radiotherapy is an alternative in centers where IMRT (intensity modulated radiation therapy) is not available.

GCP - In patients with prostate cancer at the locally advanced clinical stage with a life expectancy exceeding 10 years and a low risk of lymph node affectation (cT3a + Gleason <8 + PSA <20 ng/ml), radical prostatectomy could be considered as treatment.

GCP - In patients with prostate cancer at the locally advanced clinical stage with a life expectancy below 10 years, watchful waiting or hormone therapy may be therapeutic alternatives.

A - Neoadjuvant hormone treatment must be given to patients with prostate cancer at the locally advanced clinical stage indicated with radiation treatment.

C - The usual duration of neoadjuvant hormone treatment to radiotherapy in patients with prostate cancer at the locally advanced clinical stage is 3 months.

A - Adjuvant hormone treatment to radiotherapy is recommended for patients with prostate cancer at the locally advanced clinical stage.

D - The usual duration of adjuvant hormone treatment after radiotherapy in patients with prostate cancer at the locally advanced clinical stage is 2-3 years.

B - Neoadjuvant hormone treatment is not recommended in patients with prostate cancer at the locally advanced clinical stage who are going to have radical prostatectomy.

B - Adjuvant hormonal treatment in prostatectomy is not recommended for patients with prostate cancer at the locally advanced clinical stage, unless lymph node dissemination is demonstrated.

A - In patients with prostate cancer at the locally advanced clinical stage, primary cryotherapy and high intensity focused ultrasound are experimental techniques.

Adjuvant Radiotherapy

Question to Answer: For patients who have undergone radical prostatectomy which shows locally advanced prostate cancer and/or microscopic positive surgical margins, is it safer and more efficacious to establish an adjuvant treatment (radiotherapy) than not?

GCP - In patients with locally advanced prostate cancer and/or positive microscopic surgical margins after radical prostatectomy, systematic adjuvant radiotherapy is not recommended.

Lymphadenectomy

Question to Answer: In patients with prostate cancer at the locally advanced clinical stage in which surgery is indicated, does a lymphadenectomy increase cure rates for the disease? If so, which is better, extended or limited lymphadenectomy?

A - Lymphadenectomy should be indicated in patients with prostate cancer at a locally advanced clinical stage who have undergone radical prostatectomy, as a staging and subsequent evaluation of adjuvant treatment.

GCP - In patients with prostate cancer at a locally advanced clinical stage where radical surgery is indicated, extended lymphadenectomy may be of therapeutic interest.

Adjuvant/Neoadjuvant Hormone Therapy

Question to Answer: In patients with locally advanced prostate cancer subjected to local treatment (such as radiation or surgery) associated with hormone therapy, what form of hormone treatment is safer and more effective: monotherapy with antiandrogens, monotherapy with luteinising-hormone releasing hormone (LHRH) agonists or complete androgen blockade?

GCP - The appropriate hormonal treatment (monotherapy with antiandrogens, monotherapy with LHRH agonists or complete androgen blockade) cannot be determined for patients with prostate cancer at the locally advanced clinical stage for whom the addition of hormone therapy has been suggested.

Prostate Cancer in PSA Relapse

Definition of PSA Relapse

Question to Answer: In patients with prostate cancer undergoing prostatectomy or radiotherapy with curative intent, what would be the best analytical approach for the diagnosis of biochemical failure?

After Radiotherapy

D - In prostatectomised patients, biochemical recurrence of the disease will be considered to have occurred when serum PSA levels exceed 0.4 ng/ml.

D - In those patients whose intervention with intent to cure was radiotherapy or brachytherapy, biochemical recurrence of the disease will be considered to have occurred when serum PSA levels increase by 2 ng/ml above the PSA nadir.

Salvage Treatment After Surgery

Question to Answer: In patients with biochemical failure after radical prostatectomy, what kind of intervention is safest and most effective?

D - Patients with PSA relapse of the disease after radical prostatectomy without distant metastases or other risk factors, should be given early salvage radiotherapy before the PSA exceeds 2.5 ng/ml.

D - Salvage hormone therapy may be indicated for those men with PSA relapse after radical prostatectomy who also have local symptomatic progression, distant metastasis or duplication of PSA levels in less than 10 months.

Salvage Treatment After Radiotherapy

Question to Answer: In patients with biochemical failure after radiotherapy or brachytherapy with intent to cure, what kind of salvage intervention is safest and most effective?

D - Salvage radical prostatectomy can be offered after radiotherapy treatment for patients with local recurrence with few associated comorbidities, a life expectancy of at least 10 years, with cT1-T2, Gleason <7 and a pre-surgical PSA <10 ng/ml.

D - Hormone therapy should be considered as a salvage therapeutic option in patients treated with radiotherapy with local recurrence of the disease, who cannot be offered salvage radical prostatectomy.

D - The adoption of other salvage therapeutic alternatives (cryotherapy or high intensity focused ultrasound) should be considered as experimental.

When to Start Hormone Therapy

Question to Answer: In patients who have undergone curative treatment, are in biochemical failure and for whom hormone treatment (active treatment) is indicated, when should it start?

D - In patients with PSA relapse after radical prostatectomy in which hormonal treatment is decided, if there is a Gleason >7, PSA ≤5 ng/ml and a PSA doubling time of less than 1 year, it is recommended that hormone treatment be applied early.

GCP - In patients with PSA relapse after radiotherapy or radical brachytherapy in which hormone treatment is indicated, the decision on when to implement it should be done on an individual basis.

Intermittent vs. Continuous Hormone Therapy

Question to Answer: In patients who have undergone curative treatment, are in biochemical failure and for whom hormone treatment is indicated, which is safer and more effective: applying it continuously or intermittently?

A - In patients with PSA relapse after radical treatment in which hormone therapy has been decided, it cannot be determined whether it is better to apply it continuously or intermittently.

Disseminated Prostate Cancer

Hormone Therapy

Questions to Answer

• In patients with disseminated prostate cancer, what is the safest and most effective treatment: complete androgen blockade or (surgical or chemical) castration?
• In patients with disseminated prostate cancer (lymph node affectation and/or metastasis), what is the safest and most effective treatment: immediate or delayed hormone treatment?
• In patients with disseminated prostate cancer, what is the safest and most effective hormone treatment: continuous or intermittent? And using what treatment guidelines?
• In patients with prostate cancer where the first line hormone treatment (androgen suppression, complete androgen blockade) has failed and the PSA has begun to rise, what is the safest and most effective?

A - In patients with disseminated prostate cancer for which hormone therapy is indicated, (surgical or chemical) castration is recommended as a first-line treatment.

D - In patients with symptomatic disseminated prostate cancer, hormone treatment is recommended.

B - In patients with asymptomatic disseminated prostate cancer spread, immediate or deferred hormone therapy can be offered, the latter when symptoms appear).

GCP - In patients with disseminated prostate cancer and low tumor burden, intermittent androgen suppression can be evaluated as an alternative to continuous androgen suppression if there is a good response to initial hormone treatment.

GCP - To be able to indicate intermittent hormone therapy, the patient must have received androgen deprivation for at least 7 months and reached a PSA <4 ng/ml (stable or in decline during the sixth and seventh months), or a 90% reduction from pre-treatment levels. Monitoring will be carried out every 6 months. Patients who have stopped androgen deprivation will receive another cycle on request, when the PSA increases or when clinical symptoms of disease progression appear. If the PSA returns to normal after the new round of androgen deprivation, hormone therapy can be stopped again.

GCP - Patients with disseminated androgen-independent prostate cancer (when both androgen suppression and complete androgen blockade have failed) can be offered second-line hormone therapy before starting chemotherapy treatment.

Chemotherapy

Questions to Answer

• In patients with androgen-independent disseminated prostate cancer, what is the safest and most effective treatment for improving overall survival, clinical or biochemical response, progression-free survival and reduction of side effects: oestramustine, mitoxantrone, docetaxel, docetaxel-oestramustine, vinorelbine or etoposide?
• In patients with androgen-independent prostate cancer who are going to receive chemotherapy, is it safer and more effective to start it at biochemical failure or wait for clinical progression?
• In patients with disseminated prostate cancer in progression after hormone treatment who are going to receive chemotherapy, does removing luteinising-hormone releasing hormone (LHRH) agonists modify the safety and efficacy?

B - In patients with androgen-independent prostate cancer (AIPC) and metastasis, when chemotherapy treatment is proposed, it is recommended to use docetaxel (a 75 mg/m² dose every 3 weeks) with corticosteroid.

GCP - In patients with AIPC and metastasis, systematic association of docetaxel-oestramustine is not recommended.

GCP - In patients with biochemical relapse, who are androgen-independent, asymptomatic and without documented metastasis disease, early chemotherapy treatment may be offered, especially within the framework of randomized trials.

GCP - In patients with androgen-independence for whom chemotherapy has been decided, LHRH agonists can continue to be applied.

Bisphosphonates and Radiopharmaceuticals

Questions to Answer

• In patients with disseminated prostate cancer, does intervention with bisphosphonates (zoledronic acid) compared with doing nothing improve event-free survival for bone pain and quality of life, and does it allow a reduction in the dose of painkillers?
• In patients with disseminated prostate cancer, does administering radiopharmaceuticals provide better control and/or a reduction of metastatic bone pain?

B - Routine use of bisphosphonates (zoledronic acid) as a preventive treatment for bone complications is not recommended. Zoledronic acid (4 mg every 3 weeks) can be offered in selected patients and those who are hormone-independent or with demonstrated metastasis.

A - Treatment with Strontium-89 (Sr-89) or Samarium-153 (Sm-153) can be proposed in men with androgen-independent prostate cancer when third level analgesics are required to adequately control bone pain. A correct haematological formula (>3,500 leukocytes and >150,000 platelets) and a bone scan showing bone metastasis are essential before administration.

Definitions:

Levels of Evidence

1++ - High quality meta-analyses, systematic reviews of clinical trials or high quality clinical trials with a very low risk of bias.

1+ - Well-conducted meta-analyses, systematic reviews of clinical trials or well-conducted clinical trials with a low risk of bias.

1- - Meta-analyses, systematic reviews of clinical trials or clinical trials with a high risk of bias.

2++ - High quality systematic reviews of case control or cohort studies. High quality case control or cohort studies with very low risk of bias and a high probability of establishing a causal relationship.

2+ - Well-conducted case control or cohort studies with a low risk of bias and a moderate probability of establishing a causal relationship.

2- - Case control or cohort studies with a high risk of bias and a significant risk that the relationship is not causal.

3 - Non-analytical studies, e.g., case reports and case series.

4 - Expert opinion.

Note: Studies classified as 1- and 2- should not be used in the process of developing recommendations due to their high possibility of bias.

Grades of Recommendation

A: At least one meta-analysis, systematic review or clinical trial rated as 1++, which is directly applicable to the target population of the guideline; or a body of evidence consisting mainly of studies rated as 1+, which demonstrate overall consistency of results.

B: A body of evidence consisting mainly of studies rated as 2++, directly applicable to the target population of the guideline, which demonstrate overall consistency of results; or evidence extrapolated from studies rated as 1++ or 1+.

C: A body of evidence consisting of studies classified as 2+, directly applicable to the target population of the guideline, which demonstrate overall consistency of results; or evidence extrapolated from studies rated as 2++.

D: Evidence level 3 or 4; or extrapolated evidence from studies rated as 2+.

Good Clinical Practice (GCP)*: Recommended practice based on clinical experience and the consensus of the development group.

*Sometimes the development group was aware of some important practical aspect which needed to be emphasized but for which there was probably no evidence to support it. Generally, these cases were related to some aspect of the treatment considered as good clinical practice which nobody would normally question. These aspects were evaluated as good clinical practice points. These messages are not an alternative to recommendations based on the evidence, but must be considered only when there is no other way to highlight this aspect.

None provided

The type of supporting evidence is specifically stated for each recommendation (see the "Major Recommendations" field).

Appropriate and timely evaluation and treatment of prostate cancer

If there is an adenoma and a cancer, the prostate will be large, which contraindicates brachytherapy or ultrasound.

This Clinical Practice Guideline (CPG) is a healthcare decision aid. It is not mandatory, and it is not a substitute for the clinical judgement of healthcare personnel.

The clinical practice guidelines are an attempt to help professionals and patients make decisions about appropriate health care. This involves an investment of effort and resources which is sometimes not sufficiently exploited, due to not being sufficiently used by health professionals or due to not improving the quality of care or health outcomes in the population for which it is intended.

To improve the implementation of this guideline, that is, its use in the clinical setting, a set of strategies should be devised to overcome possible barriers to its adoption.

The plan to implement this Prostate Cancer Treatment Guideline includes the following measures:

• Presentation of the guideline by the health authorities to the media.
• Collaboration with the Scientific Organisations involved in the preparation, revision and distribution of this guideline.
• Sending the guideline to different GCP databases to be assessed and included in them.
• Contact with the Spanish Association Against Cancer and other patient groups interested in this guideline.
• Free access to the various versions of this guideline on the Health Guideline web site (http://www.guiasalud.es ).
• Spreading information about the guideline in various scientific functions related to prostate cancer (conferences, seminars, meetings).
• Sending a guideline information leaflet to professional places of learning, government health organisations, health centres, local health associations, etc.
• Placing information about the guideline in specialist medical journals and publications.
• Broadcasting the existence and objectives of this guideline via distribution lists for potentially interested practitioners.

Not applicable: The guideline was not adapted from another source.

Collaborating organizations:

• Spanish Association of Urology
• Spanish Society of Radiotherapeutic Oncology
• Spanish Society of Medical Oncology
• Spanish Association of Nursing in Urology
• Members of these organizations have participated in the authorship, expert collaboration and external review of the Clinical practice guideline (CPG).

The clinical practice guideline has been funded through the agreement signed by the Carlos III Health Institute, an independent body of the Ministry of Health and Consumer Affairs, and the Aragon Institute of Health Sciences – I+CS, in the framework of cooperation provided for in the National Health System Quality Plan.

Clinical Practice Guideline (CPG) Working Group for Prostate Cancer Treatment

Clinical Practice Guideline Working Group for Prostate Cancer Treatment: Antonio Antón Torres, Specialist in Medical Oncology, "Miguel Servet" University Hospital, Zaragoza; Ángel Borque Fernando, Specialist in Urology, "Miguel Servet" University Hospital, Zaragoza; Verónica Calderero Aragón, Specialist in Medical Oncology, "Miguel Servet" University Hospital, Zaragoza; Ricardo Escó Barón, Specialist in Radiotherapeutic Oncology, "Lozano Blesa", University Clinical Hospital, Zaragoza; Elvira Elena García Álvarez, Specialist in Preventive Medicine and Public Health, Aragon Institute of Health Sciences, Zaragoza; Mª Jesús Gil Sanz, Specialist in Urology, "Miguel Servet" University Hospital, Zaragoza; Mercedes Martín Valenciano, Nurse, "Miguel Servet" University Hospital, Zaragoza; Agustina Méndez Villalón, Specialist in Radiotherapeutic Oncology, "Miguel Servet" University Hospital, Zaragoza; Luis Plaza Mas, Specialist in Pathological Anatomy, "Miguel Servet" University Hospital, Zaragoza; Luis Ángel Rioja Sanz, Specialist in Urology, "Miguel Servet" University Hospital, Zaragoza; Alberto Sáenz Cusí, Specialist in Medical Oncology, "Lozano Blesa" University Clinical Hospital, Zaragoza; Martín Tejedor Gutiérrez, Specialist in Radiotherapeutic Oncology, "Miguel Servet" University Hospital, Zaragoza; Carmen Velilla Millán, Specialist in Radiotherapeutic Oncology, "Lozano Blesa" University Clinical Hospital, Zaragoza

Coordination - Clinical Area: Luis Ángel Rioja Sanz, Specialist in Urology, "Miguel Servet" University Hospital, Zaragoza.

Coordination - Methodological Area: Juan Ignacio Martín Sánchez, Specialist in Preventive Medicine and Public Health, Aragon Institute of Health Sciences, Zaragoza; José Mª Mengual Gil, Specialist in Paediatrics, Aragon Institute of Health Sciences, Zaragoza

Collaborators - Documentalist: Montserrat Salas Valero, Aragon Institute of Health Sciences, Zaragoza

Other collaborators: Silvia Castán Ruiz, Specialist in Preventive Medicine and Public Health, Aragon Institute of Health Sciences, Zaragoza; Raquel Espílez Ortiz, Specialist in Urology, "San Jorge" Hospital, Huesca; Alberto Fantova Alonso, Urology Resident Intern, "Miguel Servet" University Hospital, Zaragoza; Ana Marco Valdenebro, Specialist in Urology, "Miguel Servet" University Hospital, Zaragoza; Mª Pilar Medrano Llorente, Urology Resident Intern, "Royo Villanova" Hospital, Zaragoza

Expert Collaborators: Joaquín Carballido, Specialist in Urology, "Puerta de Hierro" University Hospital, Madrid; Antoni Gelabert Mas, Specialist in Urology, Hospital del Mar, Barcelona; Pedro José Prada Gómez, Specialist in Radiotherapeutic Oncology, Asturias Central Hospital University, Oviedo; Isabel Rodríguez Rodríguez, Specialist in Radiotherapeutic Oncology, "La Paz" University Hospital, Madrid; Carlos Tello Royloa, Specialist in Urology, "Vega Baja", Hospital, Orihuela (Alicante)

External Review: Joaquim Bellmunt Molins, Specialist in Medical Oncology, Hospital del Mar, Barcelona; Francisco Gómez Veiga, Specialist in Urology, Juan Canalejo Hospital Complex, La Coruña; José López Torrecilla, Specialist in Radiotherapeutic Oncology, University General Hospital, Valencia; Juan Morote Robles, Specialist in Urology, "Vall d'Hebron" Hospital, Barcelona; Alfredo Rodríguez Antolín, Specialist in Urology, "12 October" University Hospital, Madrid; Milagros Sagüillo Antolín, Nurse, Móstoles Hospital, Madrid; Anna Quintanilla Sanz, Nurse, Ponent Clinic, Lleida

All members of the Working Group, as well as persons who have participated in the expert collaboration and the external review, have declared their interests, presented in Appendix 5 of the original guideline document.

This is the current release of the guideline.

Electronic copies: Available in Portable Document Format (PDF) from the GuíaSalud Web site .

A Spanish version of the original guideline document is available in Portable Document Format (PDF) from the GuíaSalud Website .

Additional clinical practice guideline tools are available in Spanish only from the GuíaSalud Website .

Patient information can be found in the appendices of the original guideline document . A Spanish version is available in Portable Document Format (PDF) from the GuíaSalud Web site .

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

This NGC summary was completed by ECRI Institute on September 27, 2010. The information was verified by the guideline developer on October 20, 2010.

This summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.