Clinical trial · Interventional
Triptorelin and Radiation Therapy in Treating Patients Who Have Undergone Surgery for Intermediate-Risk Stage III or Stage IV Prostate Cancer
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-dimensional conformal radiation therapy | Radiation | — | UNRESOLVED |
| adjuvant therapy | Procedure | — | UNRESOLVED |
| triptorelin | Drug | Triptorelin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- A Relapse
- description
- Radiotherapy and Hormonotherapy only if relapse
- interventionNames
- Drug: triptorelin
- Procedure: adjuvant therapy
- Radiation: 3-dimensional conformal radiation therapy
- type
- EXPERIMENTAL
- label
- B Immediate treatment
- description
- Radiotherapy and Hormonotherapy at randomization
- interventionNames
- Drug: triptorelin
- Procedure: adjuvant therapy
- Radiation: 3-dimensional conformal radiation therapy
Primary outcomes (1)
- measure
- Event-free survival
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDSargos 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
- DERIVEDCampillo-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