Clinical trial · Interventional
Shorter Radiation Schedule for the Treatment of Prostate Cancer
A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer
NCT00201916CI-TRIAL-00003804completedPhase 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)
To improve the management of patients with early stage 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5250 cGy/20 fractions over 28 days | Procedure | — | UNRESOLVED |
| 6600 cGy/33 fractions over 45 days | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- 5250 cGy in 20 fractions over 28 days
- interventionNames
- Procedure: 5250 cGy/20 fractions over 28 days
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- 6600 cGy in 33 fractions over 45 days
- interventionNames
- Procedure: 6600 cGy/33 fractions over 45 days
Primary outcomes (1)
- measure
- time to PSA failure
- timeFrame
- 10 years
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * histologic diagnosis of adenocarcinoma of the prostate with no evidence of metastatic disease to the nodes, bone or lung * stage T1a moderately or poorly differentiated, T1b, T1c or T2 by the current UICC-TNM classification Exclusion Criteria: * PSA \> 40 mcg/L * previous therapy for carcinoma of the prostate other than biopsy or TURP, including patients previously on hormone therapy for treatment of their prostate cancer * prior or active malignancy other than non-melanoma skin cancer; or colon or thyroid cancer treated a minimum of five years prior to study entry and presumed cured * simulated volume exceeds 1000 cm3 * previous pelvic radiotherapy * inflammatory bowel disease * serious non-malignant disease which would preclude radiotherapy or surgical biopsy * geographic inaccessibility for follow-up * psychiatric or addictive disorder which would preclude obtaining informed consent or adherence to protocol * unable to commence radiation therapy within 26 weeks of the date of last prostatic biopsy * failure to give informed consent to participate in the study
References
Publications (1)
- RESULTLukka H, Hayter C, Julian JA, Warde P, Morris WJ, Gospodarowicz M, Levine M, Sathya J, Choo R, Prichard H, Brundage M, Kwan W. Randomized trial comparing two fractionation schedules for patients with localized prostate cancer. J Clin Oncol. 2005 Sep 1;23(25):6132-8. doi: 10.1200/JCO.2005.06.153. PMID 16135479