Clinical trial · Interventional
Hormone Therapy in Treating Patients With Advanced Prostate Cancer
Long Term Adjuvant Hormonal Treatment With LHRH Analogue Versus No Further Treatment in Locally Advanced Prostatic Carcinoma Treated by External Irradiation and a Six Months Combined Androgen Blockade - A Phase III Study
NCT00003026CI-TRIAL-00007301completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 stimulate the growth of prostate cancer cells. Hormone therapy using triptorelin may fight prostate cancer by reducing the production of androgens. PURPOSE: Randomized phase III trial to compare the effectiveness of long-term hormone therapy and triptorelin with no further treatment in treating patients who have advanced prostate cancer previously treated with radiation therapy and 6 months of androgen suppression.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bicalutamide | Drug | Bicalutamide | ALIAS |
| flutamide | Drug | Flutamide | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| triptorelin | Drug | Triptorelin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * T1c-T2a-b, N1-2 or pN1-2 (after pelvic lymphadenectomy) * T2c-T4, N0-2 * Prior external radiotherapy for locally advanced prostatic carcinoma required * Prior hormone therapy (6 months of combined androgen blockade) for locally advanced prostatic carcinoma required with PSA no greater than 150 ng/mL before administration * No progressive disease after the 6 months of combined androgen blockage * No stages T1c/T2a-b with a negative pelvic lymph nodes status that is assessed clinically or surgically * No lymph node involvement to common iliac and/or periaortic lymph nodes (M1a) * No external iliac lymph node metastasis more than 5 cm in greatest dimension (N3) * No distant metastases PATIENT CHARACTERISTICS: Age: * Any age Performance status: * WHO 0-2 Life expectancy: * At least 5 years Hematopoietic: * Hemoglobin at least 10 g/dL * WBC at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Not specified Renal: * Not specified Other: * No prior or concurrent cancers other than basal cell skin cancer * No serious nonmalignant disease resulting in a life expectancy of less than 5 years PRIOR CONCURRENT THERAPY: Biologic therapy * No prior biologic therapy for prostate cancer Chemotherapy * No prior chemotherapy for prostate cancer Endocrine therapy * See Disease Characteristics Radiotherapy * See Disease Characteristics Surgery * See Disease Characteristics
References
Publications (4)
- RESULTBolla M, de Reijke TM, Van Tienhoven G, Van den Bergh AC, Oddens J, Poortmans PM, Gez E, Kil P, Akdas A, Soete G, Kariakine O, van der Steen-Banasik EM, Musat E, Pierart M, Mauer ME, Collette L; EORTC Radiation Oncology Group and Genito-Urinary Tract Cancer Group. Duration of androgen suppression in the treatment of prostate cancer. N Engl J Med. 2009 Jun 11;360(24):2516-27. doi: 10.1056/NEJMoa0810095. PMID 19516032
- RESULTBolla M, van Tienhoven G, de Reijke TM, et al.: Concomitant and adjuvant androgen deprivation (ADT) with external beam irradiation (RT) for locally advanced prostate cancer: 6 months versus 3 years ADT--results of the randomized EORTC phase III trial 22961. [Abstract] J Clin Oncol 25 (Suppl 18): A-5014, 238s, 2007.
- RESULTGiraud JY, Dusserre A, Conil M, et al.: Results of the dummy-run of EORTC trial no.22961: a phase III study of long term hormonal treatment on locally advanced prostatic carcinoma treated by radiation therapy and a 6 months CAB. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-699, 378, 2001.
- DERIVEDKing MT, Chen MH, Collette L, Neven A, Bolla M, D'Amico AV. Association of Increased Prostate-Specific Antigen Levels After Treatment and Mortality in Men With Locally Advanced vs Localized Prostate Cancer: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Netw Open. 2021 May 3;4(5):e2111092. doi: 10.1001/jamanetworkopen.2021.11092. PMID 33999161