Clinical trial · Interventional
Study of External Beam Radiation Therapy With and Without Hormonal Therapy to Treat Prostate Cancer
A Phase III Trial of External Beam of Radiotherapy +/- Total Androgen Suppression for High Risk Clinically Organ-Confined Prostate Cancer
NCT00116220CI-TRIAL-00055835completedPhase 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)
This clinical study was to determine if the use of 6 months of total androgen suppression (hormonal therapy) when added to radiation therapy for localized-high risk prostate cancer would improve overall survival.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External Beam Radiotherapy | Radiation | — | UNRESOLVED |
| Flutamide (Eulexin) and Lupron or Zoladex | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Treatment 1
- description
- External beam radiation therapy + 6 months total androgen ablation
- interventionNames
- Drug: Flutamide (Eulexin) and Lupron or Zoladex
- Radiation: External Beam Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Treatment 2
- description
- External beam radiation therapy
- interventionNames
- Radiation: External Beam Radiotherapy
Primary outcomes (1)
- measure
- To determine if the 2 year freedom from PSA failure is increased in patients receiving total androgen suppression and radiation therapy compared to those patients receiving radiation therapy alone.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 41 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven prostate cancer * Negative bone scan * Lymph nodes by CT or MRI * Adequate blood work * Performance Status - ECOG 0-1 * Life expectancy of at least 10 years * \>40 years of age Exclusion Criteria: * Prior history of malignancy * Prior hormonal therapy or chemotherapy * Prior pelvic radiation therapy * Unable to tolerate lying still 5-10 minutes/day
References
Publications (16)
- BACKGROUNDTaneja SS. Re: Long-Term Follow-up of a Randomized Trial of Radiation with or without Androgen Deprivation Therapy for Localized Prostate Cancer. J Urol. 2016 May;195(5):1471-1473. doi: 10.1016/j.juro.2016.02.022. Epub 2016 Feb 10. No abstract available. PMID 27186728
- BACKGROUNDD'Amico AV, Chen MH, Renshaw A, Loffredo M, Kantoff PW. Long-term Follow-up of a Randomized Trial of Radiation With or Without Androgen Deprivation Therapy for Localized Prostate Cancer. JAMA. 2015 Sep 22-29;314(12):1291-3. doi: 10.1001/jama.2015.8577. No abstract available. PMID 26393854
- RESULTD'Amico AV, Manola J, Loffredo M, Renshaw AA, DellaCroce A, Kantoff PW. 6-month androgen suppression plus radiation therapy vs radiation therapy alone for patients with clinically localized prostate cancer: a randomized controlled trial. JAMA. 2004 Aug 18;292(7):821-7. doi: 10.1001/jama.292.7.821. PMID 15315996
- RESULTNguyen PL, Chen MH, Beard CJ, Suh WW, Choueiri TK, Efstathiou JA, Hoffman KE, Loffredo M, Kantoff PW, D'Amico AV. Comorbidity, body mass index, and age and the risk of nonprostate-cancer-specific mortality after a postradiation prostate-specific antigen recurrence. Cancer. 2010 Feb 1;116(3):610-5. doi: 10.1002/cncr.24818. PMID 19957321
- RESULTNguyen PL, Chen MH, Beard CJ, Suh WW, Renshaw AA, Loffredo M, McMahon E, Kantoff PW, D'Amico AV. Radiation with or without 6 months of androgen suppression therapy in intermediate- and high-risk clinically localized prostate cancer: a postrandomization analysis by risk group. Int J Radiat Oncol Biol Phys. 2010 Jul 15;77(4):1046-52. doi: 10.1016/j.ijrobp.2009.06.038. Epub 2009 Oct 26. PMID 19864082
- RESULTWo JY, Chen MH, Nguyen PL, Renshaw AA, Loffredo MJ, Kantoff PW, D'Amico AV. Evaluating the combined effect of comorbidity and prostate-specific antigen kinetics on the risk of death in men after prostate-specific antigen recurrence. J Clin Oncol. 2009 Dec 10;27(35):6000-5. doi: 10.1200/JCO.2009.23.6067. Epub 2009 Oct 26.