Prostate Reirradiation Toxicity Outcomes Feasibility Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brachytherapy, Sterotactic Body Radiotherapy.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Radiotherapy Side Effect. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
Radiotherapy is the most common curative treatment for non-metastatic prostate cancer, however up to 13% of patients will develop local recurrence within 10 years. Patients can undergo further and potentially curative treatment including salvage surgery, brachytherapy (BT), external beam radiotherapy (EBRT), high intensity focused ultrasound and cryotherapy. Systematic review shows that high dose rate (HDR) BT and stereotactic body radiotherapy (SBRT) have the best outcomes in terms of biochemical control and lowest side effects. The RO-PIP trial aims to determine the feasibility of recruitment to a trial randomising patients to salvage HDR-BT or SBRT and provide prospective data on patient recorded toxicity outcomes that will inform a future phase III trial.
The primary endpoint of the RO-PIP feasibility study is to evaluate the patient recruitment potential over 2 years to a trial randomising to either SBRT or HDR-BT for patients who develop local recurrence of prostate cancer following previous radiation therapy. The aim is to recruit 60 patients across 3 sites over 2 years and randomise 1:1 to SBRT or HDR-BT. Secondary objectives include recording clinician and patient reported outcome measures (PROMs) to evaluate treatment-related toxicity. In addition, the study aims to identify potential imaging, genomic and proteomic biomarkers that are predictive of toxicity and outcome based on hypoxia status, a prognostic marker of prostate cancer.
Interventions
- Radiation Brachytherapy
High Dose-Rate Brachytherapy - Radiation Sterotactic Body Radiotherapy
Hypofractionated External Beam Radiotherapy
Primary outcome measures
- Treatment Feasibility [Time frame: 24 months]
Secondary outcome measures (2)
- Patient Reported Toxicity [Time frame: 0-3 months and >3 months]
- Clinician Reported Toxicity [Time frame: 0-3 months and >3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05614700 · 21/YH/0305