A single arm, prospective Phase II study of Split-Course PelvicRadiotherapy for Locally Progressive, Castrate Resistant Prostate Cancer

Phase 2

• Conditions: Castrate Resistant Prostate Cancer; Cancer - Prostate

• Registration Number: ACTRN12614000858695
• Lead Sponsor: Radiation Oncology Services - Mater Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-11
• Study Completion: 2021-08-09
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

Aged 18 years or older

Has provided written Informed Consent for participation in this trial

Histological or cytologically confirmed prostate cancer or where diagnosis made on clinical factors, a PSA >100ug/L at diagnosis

Castrate resistant disease, as defined by a rising PSA despite castrate levels of testosterone <0.5 ug/L

Patient has symptoms attributable to local disease progression OR is asymptomatic with T3 or T4 disease but and felt to be at risk of symptomatic local progression (these patients to be included in analysis of secondary endpoints 1, 3 and 4)

An ECOG performance status score of 2 or less

Life expectancy at least 6 months

Available for follow up at least via a phone interview.

Radiotherapy can commence within 6 weeks of trial registration.

Is able to complete QOL assessments

Exclusion Criteria

Previous radiotherapy to the pelvis

Bilateral hip replacement surgery

Cytotoxic chemotherapy within 4 weeks of the proposed start date for radiotherapy

Prior diagnosis of cancer within 5 years of current diagnosis with the exception of successfully treated non-melanoma skin cancer

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the trial is to test the hypothesis that split-course hypo-fractionated pelvic radiotherapy improves bladder health related quality of life in patients with local symptoms associated with castrate resistant prostate cancer (CRPC). <br><br>Outcome will be assessed using the EPIC Urinary Assessment[6 months];The co-primary objective of the trial is to test the hypothesis that split-course hypo-fractionated pelvic radiotherapy improves bowel health related quality of life in patients with local symptoms associated with castrate resistant prostate cancer (CRPC).<br><br>Outcome will be assessed using the EPIC Bowel Assessment[6 months]

Secondary Outcome Measures

Name	Time	Method
To test the hypothesis that split-course hypo-fractionated pelvic radiotherapy is associated with low rates of acute and late toxicity using NCI CTCAE Version 4[6 months and 3 years respectively];To test the hypothesis that split-course hypo-fractionated pelvic radiotherapy provides effective palliation of local symptoms associated with CRPC using the EPIC Urinary and Bowel Assessments[6 months];To determine usefulness of radiotherapy in allowing freedom from indwelling catheters or ureteric stents, preventing the need for trans-urethral resections of the prostate, bladder irrigations or blood transfusions. This will be an observational assessment using patient history to report the rates of the abovementioned interventions.[3 years];To determine overall survival in this patient population[3 years]