Clinical trial · Interventional
Prostate Reirradiation Toxicity Outcomes Feasibility Study
Reirradiation Options for Previously Irradiated Prostate Cancer (RO-PIP): Feasibility Randomised Clinical Trial Investigating Toxicity Outcomes Following Reirradiation With Ultra-hypofractionated External Beam Radiotherapy vs. High Dose Rate Brachytherapy
- 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 RO-PIP trial aims to determine the feasibility of recruitment to a trial randomising patients to salvage ultra-hypofractionated external beam radiotherapy or high dose rate brachytherapy and provide prospective data on patient recorded toxicity outcomes that will inform a future phase III trial.
Conditions
Conditions (2)
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 |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brachytherapy | Radiation | — | UNRESOLVED |
| Sterotactic Body Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- High dose-rate brachytherapy
- description
- Two HDR-BT treatment schedules, either a single fraction 19Gy treatment or 27Gy in 2 fractions approximately 2 weeks apart will be used to be decided by treating centre.
- interventionNames
- Radiation: Brachytherapy
- type
- EXPERIMENTAL
- label
- Ultra-hypofractionated external beam radiotherapy
- description
- Patients will receive 5 fractions of 7.25Gy per fraction which will be delivered alternate days over no more than 2 weeks to provide a total dose of 36.25Gy.
- interventionNames
- Radiation: Sterotactic Body Radiotherapy
Primary outcomes (1)
- measure
- Treatment Feasibility
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male individuals aged over 18 years * Histologically confirmed locally recurrent prostate cancer (following previous radiotherapy no less than 2 years ago) * No metastatic disease * Able and willing to provide an informed consent to participate * World Health Organisation (WHO) performance status 0-2 * Reasonable urinary function (IPSS \< 20 and Qmax \> 10 ml/second on flow tests) * Greater than 10 year life expectancy Exclusion Criteria: * Patients who are unfit for a general anaesthetic due to other comorbidities * Clinical or radiological evidence of metastatic prostate disease * Any patient with a medical or psychiatric condition that impairs their ability to give informed consent * Contraindication or intolerance of magnetic resonance scanning * Prior prostatectomy * History of inflammatory bowel disease.
References
Publications (0)
Data not yet available