Triptorelin and Radiation Therapy in Treating Patients Who Have Undergone Surgery for Intermediate-Risk Stage III or Stage IV Prostate Cancer - Full Text View

Sponsored by:	Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00667069

Purpose

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as triptorelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving triptorelin and radiation therapy soon after surgery or later after surgery is more effective in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying giving triptorelin and radiation therapy soon after surgery to see how well it works compared with giving them later after surgery in treating patients who have undergone surgery for intermediate-risk stage III or stage IV prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Drug: triptorelin Procedure: adjuvant therapy Radiation: 3-dimensional conformal radiation therapy	Phase III

MedlinePlus related topics: Cancer Prostate Cancer Radiation Therapy Surgery

Drug Information available for: Triptorelin Triptorelin pamoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label
Official Title:	Randomized, Multicenter Study Comparing the Immediate Adjuvant Radiotherapy Associate With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) vs Delayed Radiotherapy Until Biochemical Relapse Associated With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) in Patients With Operable Prostate Cancer pT3 R1 pN0 or pNx at Intermediate Risk.

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

Primary Outcome Measures:

Event-free survival (clinical progression, biochemical progression, death) at 5 years [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Designated as safety issue: No ]
Metastases-free survival [ Designated as safety issue: No ]
Acute or chronic toxicity [ Designated as safety issue: Yes ]
Quality of life [ Designated as safety issue: No ]
Functional dependence in patients over 75 years old [ Designated as safety issue: No ]

Estimated Enrollment:	718
Study Start Date:	December 2007
Estimated Primary Completion Date:	December 2022 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Compare the efficacy, in terms of event-free survival at 5 years, of immediate radio-hormonal therapy immediately after prostatectomy for tumor pT2, R1, pN0, or pNx versus radio-hormonal therapy at biochemical relapse.

Secondary

Compare the overall survival of patients treated with these regimens.
Compare the metastasis-free survival of these patients.
Compare the acute and late toxicities of these regimens in these patients.
Compare the quality of life of patients treated with these regimens.
Compare the functional dependence of patients over 75 years old.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I (delayed treatment): Patients receive triptorelin intramuscularly on day 1 and then 3 months later. Patients also undergo conformal radiotherapy daily, 5 days a week, for 7 weeks. Treatment begins at biochemical relapse (PSA is more than 0.2 ng/mL) and before PSA is more than 2 ng/mL.
Arm II (immediate treatment): Patients receive treatment as in arm I, but treatment begins within 6 months after surgery.

After completion of study treatment, patients are followed for up to 5 years.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the prostate
- pT3a, pT3b (or pT4 by reaching the bladder neck), or R1 disease (stage III or IV)
- Localized disease
- pN0 or pNx (lymph nodes resected during negative prostatectomy or lymph nodes not resected)
- No histologically confirmed nodal involvement during initial surgery (pN1 disease)
- No pT2 disease
- No tumors of other histology than adenocarcinoma
Must have undergone curative surgery in the past 6 months
- Positive margins (tumoral glands in contact with contour ink)
No current clinical or biochemical disease
- PSA ≤ 0.1 ng/mL after prostatectomy (confirmed at 1 month)
Gleason score < 8 with no seminal vesicles involved

PATIENT CHARACTERISTICS:

ECOG performance status 0 or 1
Life expectancy ≥ 10 years
Affiliated with social security program
No history of cancer within 5 years of surgery except basal cell skin cancer
No known severe hypertension uncontrolled by appropriate therapy (≥ 160 mm Hg systolic and/or ≥ 90 mm Hg diastolic)
No known hypersensitivity to gonadotropin-releasing hormone or its analogs
No contraindication of intramuscular injection
No patients who are deprived of liberty or under guardianship
Not unable to undergo medical monitoring due to geographical, social, or psychological reasons

PRIOR CONCURRENT THERAPY:

No prior surgical or chemical castration
No prior hormonal therapy
No prior radiotherapy within 3 months after radical prostatectomy
No prior pelvic radiotherapy
No concurrent participation in another study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667069

Locations

France
Centre Alexis Vautrin	Recruiting
Vandoeuvre-les-Nancy, France, 54511
Contact: Contact Person 33-3-8359-8400
Centre Henri Becquerel	Recruiting
Rouen, France, 76038
Contact: Contact Person 33-2-3208-2222
Centre Hospitalier Lyon Sud	Recruiting
Pierre Benite, France, 69495
Contact: Contact Person 33-4-78-86-11-58
Centre Hospitalier Universitaire Henri Mondor	Recruiting
Creteil, France, 94000
Contact: Contact Person 33-1-49-812-590
Centre Leon Berard	Recruiting
Lyon, France, 69373
Contact: Contact Person 33-4-78-78-26-45
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Recruiting
Montpellier, France, 34298
Contact: Contact Person 33-4-6761-3100
Centre Regional Francois Baclesse	Recruiting
Caen, France, 14076
Contact: Contact Person 33-2-3145-5000
Centre Regional Rene Gauducheau	Recruiting
Nantes-Saint Herblain, France, 44805
Contact: Contact Person 33-2-40-479-959
Institut Gustave Roussy	Recruiting
Villejuif, France, F-94805
Contact: Contact Person 33-1-4211-4339
Clinique du Pont de Chaume	Recruiting
Montauban, France, 82017
Contact: Contact Person 33-563-683-490
Hopital Europeen Georges Pompidou	Recruiting
Paris, France, 75015
Contact: Contact Person 33-56-09-20-00
Hopital Saint Andre	Recruiting
Bordeaux, France, 33075
Contact: Contact Person 33-5-5679-5808
Hopitaux Civils de Colmar	Recruiting
Colmar, France, 68024
Contact: Contact Person 33-3-8912-4000
Institut Bergonie	Recruiting
Bordeaux, France, 33076
Contact: Contact Person 33-5-5633-3320
Institut Claudius Regaud	Recruiting
Toulouse, France, 31052
Contact: Contact Person 33-5-6142-4242
Institut de Cancerologie de la Loire	Recruiting
Saint Priest en Jarez, France, 42270
Contact: Contact Person 33-477-91-7000
CHU Poitiers	Recruiting
Poitiers, France, 86021
Contact: Contact Person 33-549-444-538

Sponsors and Collaborators

Federation Nationale des Centres de Lutte Contre le Cancer

Investigators

Study Chair:

Pierre Richaud, MD

Institut Bergonie

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000577485, FNCLCC-GETUG-17/0702, EU-20791, EUDRACT-2007-002495-34
Study First Received:	April 24, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00667069 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
stage III prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:

Antineoplastic Agents, Hormonal
Prostatic Diseases
Genital Neoplasms, Male
Contraceptive Agents
Triptorelin
Contraceptive Agents, Female

Adjuvants, Immunologic
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Contraceptive Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Urogenital Neoplasms
Reproductive Control Agents

Genital Diseases, Male
Luteolytic Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Triptorelin
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009