Clinical trial NCT05614700: Prostate Reirradiation Toxicity Outcomes Feasibility Study
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Radiotherapy Side Effect
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Feasibility Study
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Treatment Feasibility
timeFrame: 24 months
Secondary outcomes:
measure: Patient Reported Toxicity
timeFrame: 0-3 months and >3 months
measure: Clinician Reported Toxicity
timeFrame: 0-3 months and >3 months
Other outcomes:
measure: Imaging biomarkers
timeFrame: 1 month and 12 months
measure: Imaging Reproducibility
timeFrame: Baseline, 1 and 12 months
measure: Hypoxia Gene Signature
timeFrame: Baseline
measure: Proteomic Biomarkers
timeFrame: Baseline, 1, 3 and 6 months
Locations:
Study officials:
affiliation: University of Leeds
name: Ann Henry
role: PRINCIPAL_INVESTIGATOR
References: