Clinical trial · Interventional
Randomized Trial of Five or Two MRI-Guided Adaptive Radiotherapy Treatments for Prostate Cancer
Randomized Phase II Trial of Five or Two MRI-Guided Adaptive Radiotherapy Treatments for Prostate Cancer
NCT04984343CI-TRIAL-00109276FORTterminatedPhase 2ClinicalTrials.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): The study was closed prematurely due to low enrollment.
Summary
Brief summary (as posted)
The study is a randomized study that compares 5 radiation therapy treatments to 2 radiation therapy treatments in men with low or intermediate-risk 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
- EXPERIMENTAL
- label
- 5 radiation treatments - ARM 1
- description
- Patients randomized to ARM 1 will receive 37.5 in 5 radiotherapy treatments.
- interventionNames
- Radiation: Radiation Therapy
- type
- ACTIVE_COMPARATOR
- label
- 2 radiation treatments - ARM 2
- description
- Patients randomized to ARM 2 will receive 25 Gy in 2 radiotherapy treatments.
- interventionNames
- Radiation: Radiation Therapy
Primary outcomes (1)
- measure
- Change in the number of patient-reported GI symptoms using the Expanded Prostate Cancer Index Composite (EPIC)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Men aged \>=18 with histologically confirmed low or intermediate risk prostate cancer per NCCN guidelines. * ECOG 0 - 1 * IPSS \< 18 * Ability to receive MRI-guided radiotherapy. * Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. * Patients with a prior or concurrent disease whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ or low-grade non-muscle invasive bladder cancer) who has been disease-free for less than 3 years must contact the Principal Investigator. Exclusion Criteria: * Prior history of receiving pelvic radiotherapy. * Patient with history of inflammatory bowel disease. * MRI Prostate Volume \> 80 cc * MRI Stage \> T3a * Unilateral or bilateral hip replacements. * History of bladder neck or urethral stricture. * TURP \< 8 weeks prior to radiotherapy * Metastatic (pelvic nodal or distant) disease on CT, Bone, Fluciclovine, and/or PSMA PET scan
References
Publications (1)
- DERIVEDWolfe S, Diven MA, Marciscano AE, Zhou XK, Kishan AU, Steinberg ML, Miccio JA, Camilleri P, Nagar H. A randomized phase II trial of MR-guided prostate stereotactic body radiotherapy administered in 5 or 2 fractions for localized prostate cancer (FORT). BMC Cancer. 2023 Sep 30;23(1):923. doi: 10.1186/s12885-023-11430-z. PMID 37777738