Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising PSA After Surgery for Prostate Cancer - Full Text View

Sponsors and Collaborators:	Radiation Therapy Oncology Group National Cancer Institute (NCI) Cancer and Leukemia Group B
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00567580

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, and luteinizing hormone-releasing hormone agonist, may lessen the amount of androgens made by the body. It is not yet known which regimen of radiation therapy with or without androgen deprivation therapy is more effective for prostate cancer.

PURPOSE: This randomized phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Drug: bicalutamide Drug: flutamide Procedure: radiation therapy	Phase III

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Flutamide Bicalutamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized
Official Title:	A Phase III Trial of Short Term Androgen Deprivation With Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients With a Rising PSA After Radical Prostatectomy

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Freedom from progression (FFP) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary biochemical failure [ Designated as safety issue: No ]
Hormone-refractory disease [ Designated as safety issue: No ]
Local failure [ Designated as safety issue: No ]
Distant metastasis [ Designated as safety issue: No ]
Cause-specific mortality [ Designated as safety issue: No ]
Overall mortality [ Designated as safety issue: No ]
Incidence of acute adverse events ≤ 90 days of the completion of radiotherapy (RT) [ Designated as safety issue: Yes ]
Time to late grade 2+ and 3+ adverse events assessed > 90 days from the completion of RT [ Designated as safety issue: Yes ]
Comparison of disease-specific health related quality of life (HRQOL) change by EPIC, HVLT-R, Trail Making Test, parts A & B, and COWAT [ Designated as safety issue: No ]
Assessment of mood and depression change using QOL measured by the HSCL-25 [ Designated as safety issue: No ]
Assessment and comparison of Quality Adjusted Life Year (QALY) and Quality Adjusted FFP Year (QAFFPY) [ Designated as safety issue: No ]
Evaluation and comparison of the cost-utility using EQ-5D [ Designated as safety issue: No ]
Association between serum levels of beta-amyloid (Abeta) and measures of HSCL-25, the HVLT-R, Trail Making Test, parts A & B, or the COWAT [ Designated as safety issue: No ]
Prognostic value of genomic and proteomic markers for the primary and secondary clinical endpoints [ Designated as safety issue: No ]
Collection of paraffin-embedded tissue blocks, serum, plasma, urine, and buffy coat cells for future translational research analyses [ Designated as safety issue: No ]
Assessment of the relationship(s) between the American Urological Association Symptom Index (AUA SI) and urinary morbidity (Adverse Event terms: Urinary frequency/urgency) using the CTCAE v. 3.0 grading system [ Designated as safety issue: Yes ]

Estimated Enrollment:	1764
Study Start Date:	February 2008
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Active Comparator (Prostate bed radiotherapy [PBRT] alone): Patients undergo PBRT once daily, 5 days a week, Monday through Friday, for approximately 7-8 weeks (36 to 39 fractions).	Procedure: radiation therapy Once daily, 5 days a week
Arm II: Experimental (PBRT and short-term androgen deprivation [STAD]): Beginning 2 months before the start of PBRT, patients undergo short term androgen deprivation (STAD), using a combination of antiandrogen and luteinizing hormone-releasing hormone (LHRH) agonist therapy, for a total of 4-6 months. Patients receive antiandrogen therapy comprising either oral flutamide 3 times daily or oral bicalutamide once daily for at least 4 months. Patients receive LHRH agonist injection beginning concurrently with or 2 weeks after the start of antiandrogen therapy. LHRH agonist injection consist of analogs (e.g., leuprolide, goserelin, buserelin, or triptorelin) and may be given as a 1-monthly, 3-monthly, 4-monthly, or 6- monthly injection or in any combination. Total LHRH agonist treatment time is 4-6 months. Approximately 2 months after beginning of STAD, patients undergo PBRT as in arm I.	Drug: bicalutamide Oral, daily Drug: flutamide Oral, daily Procedure: radiation therapy Once daily, 5 days a week
Arm III: Experimental (Pelvic lymph node radiotherapy [PLNRT], PBRT, and STAD): Beginning 2 months before the start of radiotherapy, patients receive STAD therapy as in arm II. Approximately 2 months after beginning of STAD, patients undergo PBRT and PLNRT once daily, 5 days a week, Monday through Friday, for approximately 5 weeks (25 fractions) followed by PBRT only once daily, 5 days a week for approximately 2-3 weeks (11-14 fractions).	Drug: bicalutamide Oral, daily Drug: flutamide Oral, daily Procedure: radiation therapy Once daily, 5 days a week

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Adenocarcinoma of the prostate treated primarily with radical prostatectomy
- Pathologically proven to be lymph node-negative by pelvic lymphadenectomy (N0) or lymph node status pathologically unknown (Nx [undissected pelvic lymph nodes because lymph node dissection is not required])
- Any type of radical prostatectomy allowed, including retropubic, perineal, laparoscopic or robotically assisted
- Meets 1 of the following pathologic classifications:
  - T3 N0/Nx disease
  - T2 N0/Nx disease with positive prostatectomy margin and/or positive prostatic fossa or urethral-vesical anastomosis biopsies
- N1 patients are ineligible, as are those with pelvic lymph node enlargement ≥ 1.5 cm in greatest dimension by CT scan or MRI of the pelvis, unless the enlarged lymph node is negative
- Prostatectomy Gleason score of 8 or less
A post-radical prostatectomy entry PSA of ≥ 0.2 and < 2.0 ng/mL at least 6 weeks after prostatectomy and within 30 days of registration
PSA doubling time > 6 months prior to registration
No distant metastases based on history/physical examination, CT scan or MRI of the abdomen and pelvis, and bone scan
No palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer

PATIENT CHARACTERISTICS:

Zubrod performance status 0-1
Platelets ≥ 100,000/mm^3
Hemoglobin ≥ 12.0 g/dL (the use of transfusion or other intervention to achieve this is allowed)
AST or ALT < 2 x upper limit of normal
No prior invasive malignancy (except nonmelanoma skin cancer) unless disease-free for a minimum of 5 years (e.g., carcinoma in situ of the oral cavity is permissible)
No severe, active co-morbidity, including any of the following:
- History of inflammatory bowel disease
- History of hepatitis B or C
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Acquired immune deficiency syndrome (AIDS) based upon current CDC definition
  - HIV testing is not required for entry
No prior allergic reaction to the study drug(s) involved in this protocol

PRIOR CONCURRENT THERAPY:

No androgen deprivation therapy started prior to prostatectomy for > 6 months duration
No androgen deprivation therapy started after prostatectomy and prior to registration
No prior pelvic radiotherapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567580

Show 146 Study Locations

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Cancer and Leukemia Group B

Investigators

Study Chair:	Alan Pollack, MD, PhD	Fox Chase Cancer Center
Investigator:	Leonard G. Gomella, MD	Jefferson Medical College of Thomas Jefferson University
Study Chair:	Joycelyn L. Speight, MD, PhD	UCSF Helen Diller Family Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000577574, RTOG-0534
Study First Received:	December 4, 2007
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00567580
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage II prostate cancer
stage III prostate cancer
adenocarcinoma of the prostate

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Bicalutamide
Urogenital Neoplasms

Flutamide
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:

Androgen Antagonists
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses

Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009