Prostate Reirradiation Toxicity Outcomes Feasibility Study

NCT ID: NCT05614700

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2026-11-15

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.

Conditions

Prostate Cancer; Radiotherapy Side Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High dose-rate brachytherapy

Two HDR-BT treatment schedules, either a single fraction 19Gy treatment or 27Gy in 2 fractions approximately 2 weeks apart will be used to be decided by treating centre.

Group Type: ACTIVE_COMPARATOR

Brachytherapy

Intervention Type: RADIATION

High Dose-Rate Brachytherapy

Ultra-hypofractionated external beam radiotherapy

Patients will receive 5 fractions of 7.25Gy per fraction which will be delivered alternate days over no more than 2 weeks to provide a total dose of 36.25Gy.

Group Type: EXPERIMENTAL

Sterotactic Body Radiotherapy

Intervention Type: RADIATION

Hypofractionated External Beam Radiotherapy

Interventions

Brachytherapy

High Dose-Rate Brachytherapy

Intervention Type: RADIATION

Sterotactic Body Radiotherapy

Hypofractionated External Beam Radiotherapy

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Leeds

OTHER

Sponsor Role: lead

Responsible Party

Ann Henry

Associate Professor in Clinical Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ann Henry

Role: PRINCIPAL_INVESTIGATOR

University of Leeds

Central Contacts

Ann Henry

Role: CONTACT

a.henry@leeds.ac.uk

0113 2067630

Jim Zhong

Role: CONTACT

j.zhong@leeds.ac.uk

0113 2067630

Other Identifiers

21/YH/0305

Identifier Type: -

Identifier Source: org_study_id