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

• Status: Active, not recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Collaborator: Ipsen
• Treatments: Triptorelin Pamoate

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