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

NCT ID: NCT00667069

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 424 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-07
• Study Completion Date: 2022-05-24

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.

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A Relapse

Radiotherapy and Hormonotherapy only if relapse

Group Type: OTHER

triptorelin

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

B Immediate treatment

Radiotherapy and Hormonotherapy at randomization

Group Type: EXPERIMENTAL

triptorelin

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

Interventions

triptorelin

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

Other Intervention Names

Decapeptyl

Eligibility Criteria

Inclusion Criteria

1. Patient must have undergone curative surgery for a localized adenocarcinoma of the prostate

2. pT3a, pT3b (or pT4 by reaching the bladder neck), or R1 disease (stage III or IV)

3. PSA ≤0.1 ng/mL after prostatectomy (confirmed at 1 month)

4. May receive treatment within 6 months after surgery

5. Positive margins (tumoral glands in contact with contour ink) on the surgical specimen

6. pN0 or pNx (lymph nodes resected during negative prostatectomy or lymph nodes not resected)

7. No current clinical or biochemical progressive disease

8. Life expectancy ≥10 years

9. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

10. Patient must be affiliated to the social security system

11. Patient must have received the information sheet and signed the consent form

Exclusion Criteria

1. Patient with prostate cancer other than adenocarcinoma

2. Gleason score ≥8 and with seminal vesicles involved

3. pN1 disease (Histologically confirmed nodal invasion during initial lymph node resection)

4. pT2 disease

5. Prior surgical or chemical castration

6. Prior hormonal therapy

7. Prior radiotherapy within 3 months after radical prostatectomy

8. Prior pelvic radiotherapy

9. No history of cancer (except basal cell skin cancer) within 5 years of surgery

10. No known severe hypertension uncontrolled by appropriate therapy (≥160 mm Hg systolic and/or ≥90 mm Hg diastolic)

11. Known hypersensitivity to gonadotropin-releasing hormone or its analogs

12. Contraindication to intramuscular injection

13. Concurrent participation in another interventional study

14. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: collaborator

UNICANCER

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Richaud, MD

Role: STUDY_CHAIR

Institut Bergonié

Locations

Hopital Saint Andre

Bordeaux, , France

Institut Bergonie

Bordeaux, , France

Centre Regional Francois Baclesse

Caen, , France

Hopitaux Civils de Colmar

Colmar, , France

Centre Hospitalier Universitaire Henri Mondor

Créteil, , France

Centre Leon Berard

Lyon, , France

Clinique du Pont de Chaume

Montauban, , France

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

Montpellier, , France

Hopital Europeen Georges Pompidou

Paris, , France

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

CHU Poitiers

Poitiers, , France

Centre Henri Becquerel

Rouen, , France

Centre Regional Rene Gauducheau

Saint-Herblain, , France

Institut de Cancerologie de la Loire

Saint-Priest-en-Jarez, , France

Institut Claudius Regaud

Toulouse, , France

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, , France

Institut Gustave Roussy

Villejuif, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 33002438 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25592642 (View on PubMed)

Other Identifiers

2007-002495-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CDR0000577485

Identifier Type: OTHER

Identifier Source: secondary_id

GETUG-AFU 17 - UC-0160/0702

Identifier Type: -

Identifier Source: org_study_id