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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2008 by National Cancer Institute (NCI)
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00667069
First received: April 24, 2008
Last updated: February 6, 2009
Last verified: April 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00667069     History of Changes
Other 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
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Triptorelin
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 09, 2014