Prostate Reirradiation Toxicity Outcomes Feasibility Study

Trial Title: Prostate Reirradiation Toxicity Outcomes Feasibility Study

NCT ID: NCT05614700

Condition: Prostate Cancer
Radiotherapy Side Effect

Conditions: Official terms:
Prostatic Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Randomised Feasibility Study

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Brachytherapy
Description: High Dose-Rate Brachytherapy
Arm group label: High dose-rate brachytherapy

Intervention type: Radiation
Intervention name: Sterotactic Body Radiotherapy
Description: Hypofractionated External Beam Radiotherapy
Arm group label: Ultra-hypofractionated external beam radiotherapy

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.

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.

Criteria for 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.

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: November 15, 2022

Completion date: November 15, 2026

Lead sponsor:
Agency: University of Leeds
Agency class: Other

Source: University of Leeds

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05614700