Clinical trial · Interventional
Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial
NCT00243646CI-TRIAL-00021736terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor accrual
Summary
Brief summary (as posted)
Determine the role of androgen deprivation therapy in high risk patients receiving 45 Gy of pelvic radiotherapy plus a Pd-103 boost and the impact of the duration of ADT in hormonally-manipulated patients.
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 |
|---|---|---|---|
| Casodex | Drug | Bicalutamide | ALIAS |
| External beam radiation | Radiation | — | UNRESOLVED |
| Lupron | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- no hormones
- description
- All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant with no hormones
- interventionNames
- Radiation: External beam radiation
- type
- ACTIVE_COMPARATOR
- label
- 9 months of hormone therapy
- description
- All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant with a 9 month course of hormone therapy
- interventionNames
- Radiation: External beam radiation
- Drug: Lupron
- Drug: Casodex
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * High risk patients - Two to three of the following: PSA 10-30 ng/mL, Gleason score greater than or equal to 6, clinical stage greater than or equal to T2c (2002 ACJJ). * CT of the abdomen and pelvis and bone scan without evidence of metastases. * An enzymatic prostatic acid phosphatase must be obtained prior to randomization. * A serum testosterone must be obtained prior to initiation of androgen deprivation therapy. * No prior pelvic external beam radiation therapy for prostate cancer or other malignancies. * No prior androgen deprivation therapy. * Minimum 5 year life expectancy. * No other invasive cancer diagnosis other than non-melanoma skin cancer within the last 5 years. Exclusion Criteria: * Exclusion criteria will be limited to patients who do not meet the above eligibility criteria.
References
Publications (15)
- BACKGROUNDMerrick GS, Wallner KE, Butler WM. Permanent interstitial brachytherapy for the management of carcinoma of the prostate gland. J Urol. 2003 May;169(5):1643-52. doi: 10.1097/01.ju.0000035544.25483.61. PMID 12686802
- BACKGROUNDBolla M, Collette L, Blank L, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Mattelaer J, Lopez Torecilla J, Pfeffer JR, Lino Cutajar C, Zurlo A, Pierart M. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet. 2002 Jul 13;360(9327):103-6. doi: 10.1016/s0140-6736(02)09408-4. PMID 12126818
- BACKGROUNDPilepich MV, Caplan R, Byhardt RW, Lawton CA, Gallagher MJ, Mesic JB, Hanks GE, Coughlin CT, Porter A, Shipley WU, Grignon D. Phase III trial of androgen suppression using goserelin in unfavorable-prognosis carcinoma of the prostate treated with definitive radiotherapy: report of Radiation Therapy Oncology Group Protocol 85-31. J Clin Oncol. 1997 Mar;15(3):1013-21. doi: 10.1200/JCO.1997.15.3.1013. PMID 9060541
- BACKGROUNDRoach M 3rd, DeSilvio M, Lawton C, Uhl V, Machtay M, Seider MJ, Rotman M, Jones C, Asbell SO, Valicenti RK, Han S, Thomas CR Jr, Shipley WS; Radiation Therapy Oncology Group 9413. Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression: Radiation Therapy Oncology Group 9413. J Clin Oncol. 2003 May 15;21(10):1904-11. doi: 10.1200/JCO.2003.05.004. PMID 12743142
- BACKGROUNDD'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
- BACKGROUNDCrook J, Ludgate C, Malone S, Lim J, Perry G, Eapen L, Bowen J, Robertson S, Lockwood G. Report of a multicenter Canadian phase III randomized trial of 3 months vs. 8 months neoadjuvant androgen deprivation before standard-dose radiotherapy for clinically localized prostate cancer. Int J Radiat Oncol Biol Phys. 2004 Sep 1;60(1):15-23. doi: 10.1016/j.ijrobp.2004.02.022.