Clinical trial · Interventional
Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate Cancer
A Phase III Intensity Modulated Radiotherapy Dose Escalation Trial for Prostate Cancer Using Hypofractionation
NCT00062309CI-TRIAL-00021223completedPhase 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: Radiation therapy uses high-energy x-rays and other sources of radiation to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating prostate cancer. PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with 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 |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CIMRT
- description
- 76 Gy in 38 fractions
- interventionNames
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- HIMRT
- description
- 70.2 Gy in 26 fractions
- interventionNames
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Freedom from biochemical and/or disease failure rates
- timeFrame
- weekly during treatment, at 3 months, 6 months or 2 years then yearly
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Clinical stage T1b-T3c disease * No clinical or radiographic evidence of metastasis * Prostate-specific antigen (PSA) less than 80 ng/mL * Gleason score at least 5 * One of the following criteria must be met: * PSA greater than 10 ng/mL * Gleason score greater than 6 * T2b or greater palpable disease * Three or more biopsy cores involved with a Gleason score of at least 5 PATIENT CHARACTERISTICS: Age * Not specified Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No other medical condition that would preclude study participation * No other active malignancy within the past 5 years except nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic leukemia) * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * No more than 4 months of prior androgen deprivation therapy * Neoadjuvant and adjuvant androgen deprivation therapy is allowed for high-risk disease only Radiotherapy * No prior pelvic radiotherapy Surgery * No prior or planned radical prostate surgery
References
Publications (3)
- BACKGROUNDPollack A, Bae K, Khor LY, et al.: Stability of tumor biomarkers in archival tissue from men treated with radiotherapy for prostate cancer: an analysis of RTOG 92-02 and Fox Chase randomized trials. [Abstract] Int J Biol Markers 22 (1): 72-3, 2006.
- DERIVEDAvkshtol V, Ruth KJ, Ross EA, Hallman MA, Greenberg RE, Price RA Jr, Leachman B, Uzzo RG, Ma C, Chen D, Geynisman DM, Sobczak ML, Zhang E, Wong JK, Pollack A, Horwitz EM. Ten-Year Update of a Randomized, Prospective Trial of Conventional Fractionated Versus Moderate Hypofractionated Radiation Therapy for Localized Prostate Cancer. J Clin Oncol. 2020 May 20;38(15):1676-1684. doi: 10.1200/JCO.19.01485. Epub 2020 Mar 2. PMID 32119599
- DERIVEDPollack A, Walker G, Horwitz EM, Price R, Feigenberg S, Konski AA, Stoyanova R, Movsas B, Greenberg RE, Uzzo RG, Ma C, Buyyounouski MK. Randomized trial of hypofractionated external-beam radiotherapy for prostate cancer. J Clin Oncol. 2013 Nov 1;31(31):3860-8. doi: 10.1200/JCO.2013.51.1972. Epub 2013 Oct 7. PMID 24101042