Clinical trial · Interventional
Randomized Phase II Trial of Salvage Radiotherapy for Prostate Cancer In 4 Weeks v. 2 Weeks
NCT04422132CI-TRIAL-00104235active not recruitingPhase 2ClinicalTrials.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)
The purpose of this study is to compare urinary and bowel side effects of hypofractionated radiotherapy in 20 treatments (4 weeks) to ultra-hypofractionated radiotherapy in 5 treatments (2 weeks) for prostate cancer that has returned after prostatectomy. The investigators are also interested in looking at time to progression and the quality of life (health scores).
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 |
|---|---|---|---|
| 20 days Radiation therapy (55 Gy in 20 fractions) | Radiation | — | UNRESOLVED |
| 5 days Radiation Therapy (32.5 Gy in 5 fractions) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ARM 1 - 2 weeks
- description
- Patients will receive treatment to the prostate fossa +/- nodes in 32.5 Gy in 5 fractions. Patients receiving 32.5 Gy in 5 fractions cannot be treated on consecutive days.
- interventionNames
- Radiation: 5 days Radiation Therapy (32.5 Gy in 5 fractions)
- type
- ACTIVE_COMPARATOR
- label
- ARM 2 - 4 weeks
- description
- Patients will receive treatment to the prostate fossa +/- nodes in 55 Gy in 20 fractions.
- interventionNames
- Radiation: 20 days Radiation therapy (55 Gy in 20 fractions)
Primary outcomes (1)
- measure
- Change in the number of patient-reported GI symptoms using the Expanded Prostate Cancer Index Composite (EPIC)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Men aged 18 and older with histologically confirmed prostate cancer after prostatectomy with detectable PSA. PSA does not need to be detectable for men with pathologically node positive disease. * KPS \>=70 * Patient with no evidence of distant metastatic disease on PET/CT/MRI or bone scan \< 9 months prior to enrollment. Patients with positive pelvic lymph nodes are eligible. * Ability to receive MRI-guided radiotherapy. * Equivocal evidence of metastatic disease outside the pelvis on standard imaging requires documented negative biopsy. * Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. Exclusion Criteria: * Prior history of receiving pelvic radiotherapy. * Patient with inflammatory bowel disease. * Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of ultra-hypofractionated radiotherapy. * History of bladder neck or urethral stricture.
References
Publications (1)
- DERIVEDMarciscano AE, Wolfe S, Zhou XK, Barbieri CE, Formenti SC, Hu JC, Molina AM, Nanus DM, Nauseef JT, Scherr DS, Sternberg CN, Tagawa ST, Nagar H. Randomized phase II trial of MRI-guided salvage radiotherapy for prostate cancer in 4 weeks versus 2 weeks (SHORTER). BMC Cancer. 2023 Aug 22;23(1):781. doi: 10.1186/s12885-023-11278-3. PMID 37608258