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NCT05614700
Prostate Reirradiation Toxicity Outcomes Feasibility Study
Conditions: Prostate Cancer, Radiotherapy Side Effect
Sex: Male
Ages: 18 Years – N/A
Phase: NA
Enrollment: 60
Sponsor: University of Leeds
Summary
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.
Eligibility Criteria
Inclusion Criteria:Male individuals aged over 18 yearsHistologically confirmed locally recurrent prostate cancer (following previous radiotherapy no less than 2 years ago)No metastatic diseaseAble and willing to provide an informed consent to participateWorld Health Organisation (WHO) performance status 0-2Reasonable urinary function (IPSS < 20 and Qmax > 10 ml/second on flow tests)Greater than 10 year life expectancyExclusion Criteria:Patients who are unfit for a general anaesthetic due to other comorbiditiesClinical or radiological evidence of metastatic prostate diseaseAny patient with a medical or psychiatric condition that impairs their ability to give informed consentContraindication or intolerance of magnetic resonance scanningPrior prostatectomyHistory of inflammatory bowel disease.
Source: ClinicalTrials.gov (NCT05614700). StuddyBuddy aggregates publicly available trial information.
