A study assessing the feasibility, toxicity and efficacy of Magnetic Resonance Imaging guided stereotactic radiotherapy to locally recurrent prostate tumours after prior radiotherapy

Not Applicable

Recruiting

• Conditions: Prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12621000227897
• Lead Sponsor: Christopher Rumley

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-04
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

Histologically confirmed recurrent prostate cancer, previously treated with external beam radiotherapy or low dose rate (LDR) brachytherapy
- At least 2 years between completion of primary radiotherapy course and detection of biochemical failure as per by Phoenix definition (PSA nadir + 2)
- Prostate Specific Antigen (PSA) doubling time > 6 months
- Life expectancy > 5 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Magnetic Resonance Imaging (MRI) and/or Prostate Specific Membrane Antigen Positron Emission Tomography (PSMA PET) demonstrating locally recurrent disease involving a single focus within the prostate or seminal vesicles (i.e. multifocal recurrence not permitted)
- Patients with metastatic disease may be enrolled provided they have oligometastases to no more than 5 sites (lymph node or bone), and all sites are amenable to surgery or Stereotactic Ablative Body Radiotherapy (SABR)
- Concomitant use of androgen deprivation therapy (ADT) is permissible, but only patients who are not on ADT at the time of enrolment will be analysed for time to second biochemical failure
- Able to provide written informed consent

Exclusion Criteria

- Prior prostatectomy
- Inability to undergo MRI (per department MRI safety protocol)
- Any Grade 2 or higher late genitourinary toxicity believed to be directly related to prior radiotherapy (except in sexual function domain)
- Any Grade 2 or higher late gastrointestinal toxicity believed to be directly related to prior radiotherapy
- PSA greater than 20ug/L at time of relapse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility, as determined by the ability to complete treatment in under 90 minutes in 90% of treatments. Time taken to deliver individual treatments will be recorded with time stamps at multiple steps of the treatment pathway and logged on a database. [Feasibility will be assessed immediately after each treatment (and defined as successful if treatment was completed in under 90 minutes) until all patients have completed their treatment.]