Prostate Reirradiation Toxicity Outcomes Feasibility Study

Prostate Cancer Clinical Trial

— RO-PIP  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05614700
• Other study ID #: 21/YH/0305
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: November 15, 2026

Study information

• Verified date: November 2022
• Source: University of Leeds
• Contact: Ann Henry
• Phone: 0113 2067630
• Email: a.henry[@]leeds.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 15, 2026
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Radiotherapy Side Effect

Intervention

Radiation:
• Brachytherapy
High Dose-Rate Brachytherapy
• Sterotactic Body Radiotherapy
Hypofractionated External Beam Radiotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Leeds

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Imaging biomarkers	MRI biomarkers at 1 month and 1 year post-treatment predictive of toxicity based on PROMs.	1 month and 12 months
Other	Imaging Reproducibility	Multiple measures of image quality and reproducibility of prostate functional imaging (e.g. diffusion coefficient values from IVIM sequences) for measuring tumour biology will be summarised.	Baseline, 1 and 12 months
Other	Hypoxia Gene Signature	Hypoxia levels based on a hypoxia associated gene signature obtained from the pre-salvage RT biopsy correlated with MRI biomarkers.	Baseline
Other	Proteomic Biomarkers	Changes in the levels of inflammatory cytokine signatures from urine and blood obtained at baseline and after reirradiation in relation to PROMs.	Baseline, 1, 3 and 6 months
Primary	Treatment Feasibility	Recruitment rates for the whole 24-month recruitment period will be reported overall and per recruiting site. The average recruitment rate per month and in total over the formal monitoring period will be reported.	24 months
Secondary	Patient Reported Toxicity	Incidence of patient reported acute (0-3 months) and long-term toxicity (>3 months) and impact on QoL determined by EPIC-26 (prostate cancer related QoL and functional outcomes), EORTC QLQ-C30 (general QoL score) and international prostate symptom score (IPSS) (urinary and sexual functional outcomes) measurements (Key secondary endpoint).	0-3 months and >3 months
Secondary	Clinician Reported Toxicity	Incidence of clinician-reported treatment toxicity as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	0-3 months and >3 months