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

NCT00667069 | Completed Phase 3 DMC

• 3 other identifiers: GETUG-AFU 17 - UC-0160/07022007-002495-34CDR0000577485
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  The event-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse (clinical progression, biochemical progression, death)

  From randomization to disease progression or death, up to 5 years

Secondary Outcomes (6)

• Overall survival

  From randomization to death from any cause, up to 10 years

• Metastases-free survival

  From randomization to metastases onset, up to 10 years

• Acute or chronic toxicity

  Throughout study completion, up to 10 years

• Quality of life questionnaire - Core 30 (QLQ-C30)

  At baseline, 2 years, and 5 years

• Quality of Life Questionnaire - Prostate Cancer Module (QLQ-PR25)

  At baseline, 2 years, and 5 years

Study Arms (2)

A Relapse

OTHER

Radiotherapy and Hormonotherapy only if relapse

Drug: triptorelin; Procedure: adjuvant therapy; Radiation: 3-dimensional conformal radiation therapy

B Immediate treatment

EXPERIMENTAL

Radiotherapy and Hormonotherapy at randomization

Drug: triptorelin; Procedure: adjuvant therapy; Radiation: 3-dimensional conformal radiation therapy

Interventions

triptorelin DRUG

Also known as: Decapeptyl

A Relapse; B Immediate treatment

adjuvant therapy PROCEDURE

A Relapse; B Immediate treatment

3-dimensional conformal radiation therapy RADIATION

A Relapse; B Immediate treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must have undergone curative surgery for a localized adenocarcinoma of the prostate
• pT3a, pT3b (or pT4 by reaching the bladder neck), or R1 disease (stage III or IV)
• PSA ≤0.1 ng/mL after prostatectomy (confirmed at 1 month)
• May receive treatment within 6 months after surgery
• Positive margins (tumoral glands in contact with contour ink) on the surgical specimen
• pN0 or pNx (lymph nodes resected during negative prostatectomy or lymph nodes not resected)
• No current clinical or biochemical progressive disease
• Life expectancy ≥10 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Patient must be affiliated to the social security system
• Patient must have received the information sheet and signed the consent form

You may not qualify if:

• Patient with prostate cancer other than adenocarcinoma
• Gleason score ≥8 and with seminal vesicles involved
• pN1 disease (Histologically confirmed nodal invasion during initial lymph node resection)
• pT2 disease
• Prior surgical or chemical castration
• Prior hormonal therapy
• Prior radiotherapy within 3 months after radical prostatectomy
• Prior pelvic radiotherapy
• No history of cancer (except basal cell skin cancer) within 5 years of surgery
• No known severe hypertension uncontrolled by appropriate therapy (≥160 mm Hg systolic and/or ≥90 mm Hg diastolic)
• Known hypersensitivity to gonadotropin-releasing hormone or its analogs
• Contraindication to intramuscular injection
• Concurrent participation in another interventional study
• Patients under protective custody or guardianship, unable to comply with the specific requirements of the study or unable to understand the purpose of the study

Sponsors & Collaborators

• UNICANCER: lead
• Ipsen: collaborator

Study Sites (17)

Hopital Saint Andre

Bordeaux, 33075, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Hopitaux Civils de Colmar

Colmar, 68024, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94000, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Clinique du Pont de Chaume

Montauban, 82017, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre Regional Rene Gauducheau

Saint-Herblain, 44805, France

Location

Institut de Cancerologie de la Loire

Saint-Priest-en-Jarez, 42270, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Related Publications (2)

• Sargos P, Chabaud S, Latorzeff I, Magne N, Benyoucef A, Supiot S, Pasquier D, Abdiche MS, Gilliot O, Graff-Cailleaud P, Silva M, Bergerot P, Baumann P, Belkacemi Y, Azria D, Brihoum M, Soulie M, Richaud P. Adjuvant radiotherapy versus early salvage radiotherapy plus short-term androgen deprivation therapy in men with localised prostate cancer after radical prostatectomy (GETUG-AFU 17): a randomised, phase 3 trial. Lancet Oncol. 2020 Oct;21(10):1341-1352. doi: 10.1016/S1470-2045(20)30454-X.

  PMID: 33002438 DERIVED

• Campillo-Gimenez B, Buscail C, Zekri O, Laguerre B, Le Prise E, De Crevoisier R, Cuggia M. Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials. Trials. 2015 Jan 16;16:15. doi: 10.1186/s13063-014-0535-7.

  PMID: 25592642 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Triptorelin Pamoate; Chemotherapy, Adjuvant; Radiotherapy, Conformal

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy, Computer-Assisted; Radiotherapy

Study Officials

• Pierre Richaud, MD

  Institut Bergonié

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 25, 2008
• Study Start: April 7, 2008
• Primary Completion: April 1, 2020
• Study Completion: May 24, 2022
• Last Updated: June 5, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (17)