Clinical trial · Interventional
PROFIT - Prostate Fractionated Irradiation Trial
A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer
NCT00304759CI-TRIAL-00028838completedPhase 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 trial is designed to determine whether an 8-week course of escalated dose conformal radiation can be compressed safely, and with similar efficacy into a 4-week course.
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 |
|---|---|---|---|
| 6000 cGy/20 fractions in 4 weeks | Procedure | — | UNRESOLVED |
| 7800 cGy/39 fractions in 8 weeks | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- 6000 cGy / 20 fractions in 4 weeks
- interventionNames
- Procedure: 6000 cGy/20 fractions in 4 weeks
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- 7800 cGy / 39 fractions in 8 weeks
- interventionNames
- Procedure: 7800 cGy/39 fractions in 8 weeks
Primary outcomes (1)
- measure
- Biochemical (PSA) Failure
- timeFrame
- five years
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: 1. Histologic diagnosis of carcinoma of the prostate within 6 months of entry without evidence of metastatic disease to the lymph nodes, bone or lung; 2. Intermediate risk prostate cancer (that is, T1-2a, Gleason score \<6, PSA 10.1-20.0 ng/ml; T2b-c Gleason \<6, PSA ≤ 20.0 ng/ml; T1-2, Gleason 7, PSA ≤ 20.0 ng/ml). Exclusion Criteria: 1. Histologic diagnosis of carcinoma of the prostate more than six months prior to study entry; 2. Previous therapy for carcinoma of the prostate other than biopsy or transurethral resection; 3. Patients previously on more than 12 weeks of hormone therapy for treatment of their prostate cancer; 4. Any other active malignancy (untreated, progressive or recurrent), except for non-melanoma skin cancer. Any inactive malignancy diagnosed within 5 years of entry, except for non-melanoma skin cancer; 5. Treatment plan cannot meet dose constraints for the hypofractionation arm of the trial; 6. Previous pelvic radiotherapy; 7. Inflammatory bowel disease.
References
Publications (3)
- BACKGROUNDMartin J, Frantzis J, Chung P, Langah I, Crain M, Cornes D, Plank A, Finch T, Jones M, Khoo E, Catton C. Prostate radiotherapy clinical trial quality assurance: how real should real time review be? (A TROG-OCOG Intergroup Project). Radiother Oncol. 2013 Jun;107(3):333-8. doi: 10.1016/j.radonc.2013.05.015. Epub 2013 Jun 8. PMID 23751377
- DERIVEDSanmamed N, Dayes I, Catton C, Liu A, Supiot S, Lukka H, Bauman G, Liu Z, Bahary JP, Ahmed S, Cheung P, Parliament M, Sia M, Tsakiridis T, Siva S, Corbett T, Tang C, Craig T, Martin J, Chung P. Patient-reported Quality of Life in PROFIT, a Phase 3 Randomized Clinical Trial Evaluating Moderately Hypofractionated Radiotherapy for Intermediate-risk Prostate Cancer. Eur Urol Oncol. 2026 Feb;9(1):26-36. doi: 10.1016/j.euo.2025.03.017. Epub 2025 May 6. PMID 40335398
- DERIVEDLange M, Campion L, Ollivier L, Renouf M, Magne N, Latorzeff I, Pommier P, Martin E, Paumier A, Bera G, Catton C, Martin J, Supiot S. Patterns of Relapse Following Radiation Therapy of Intermediate-Risk Prostate Cancer in the PROFIT Randomized Trial. Int J Radiat Oncol Biol Phys. 2025 Jun 1;122(2):399-406. doi: 10.1016/j.ijrobp.2025.01.030. Epub 2025 Feb 4. PMID 39914555