NCT05614700Not yet recruiting
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 · Last updated 15 Nov 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 1 Nov 2022
- Start date
- 15 Nov 2022
- Primary completion date
- 15 Nov 2024
- Lead sponsor
- University of Leeds
- Diseases
- Prostate cancer
- NCT number
- NCT05614700
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 15 Nov 2022 to the primary completion date, 15 Nov 2024
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior prostatectomy
Other illness
- Clinical or radiological evidence of metastatic prostate disease
- Any patient with a medical or psychiatric condition that impairs their ability to give informed consent
- History of inflammatory bowel disease.
Other
- Patients who are unfit for a general anaesthetic due to other comorbidities
- Contraindication or intolerance of magnetic resonance scanning
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.