Clinical trial · Interventional
Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer
Phase III Randomized Study of Radiotherapy to the Prostate With or Without Radiotherapy to the Pelvis in Patients With Stage I, II, or III Adenocarcinoma of the Prostate
- 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: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy to the prostate and pelvis is more effective than radiation therapy to the prostate alone in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the prostate with or without radiation to the pelvis in treating patients with stage I, stage II, or stage III 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven adenocarcinoma of the prostate * Stage I (T1b or T1c, N0, M0) * Stage II (T2, N0, M0) * Stage III (T3, N0, M0) * Poor prognosis (high risk of lymph node invasion) defined as meeting at least 1 of the following criteria: * Gleason score at least 7 * Prostate-specific antigen (PSA) at least 3 times upper limit of normal (ULN) * T3 OR * Good prognosis defined as meeting 1 of the following criteria: * T1b or T2 * T1c with Gleason score less than 7 and PSA less than 3 times ULN * No metastases by bone scans or chest x-ray PATIENT CHARACTERISTICS: Age: * 75 and under Performance status: * Karnofsky 70-100% Life expectancy: * More than 10 years Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No other malignancy within the past 10 years except basal cell skin cancer * No adenopathies PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * At least 2-6 months since prior hormonal therapy, if duration no greater than 4-8 months * No concurrent luteinizing hormone-releasing hormone agonists * No concurrent anti-androgen therapy * No concurrent hormonal therapy in high-risk group Radiotherapy: * No prior pelvic radiotherapy Surgery: * No prior lymphadenectomy * No prior surgical castration * No prior prostatectomy * At least 1 month since prior transurethral resection
References
Publications (2)
- RESULTPommier P, Chabaud S, Lagrange JL, Richaud P, Lesaunier F, Le Prise E, Wagner JP, Hay MH, Beckendorf V, Suchaud JP, Pabot du Chatelard PM, Bernier V, Voirin N, Perol D, Carrie C. Is there a role for pelvic irradiation in localized prostate adenocarcinoma? Preliminary results of GETUG-01. J Clin Oncol. 2007 Dec 1;25(34):5366-73. doi: 10.1200/JCO.2006.10.5171. PMID 18048817
- RESULTPommier P, Perol D, Lagrange J, et al.: Does pelvis and prostate radiation therapy compared to prostate radiation therapy alone improve survival in patients with non metastatic prostate carcinoma? Preliminary results of the prospective randomized GETUG 01 trial. [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-33, S19, 2005.