ACTRN12621000227897
Recruiting
未知
Feasibility of Magnetic Resonance Imaging guided stereotactic reirradiation in patients who have previously received radiation for prostate cancer and have biochemical and local recurrence of cancer within the prostate
Christopher Rumley0 sites25 target enrollmentMarch 4, 2021
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Prostate cancer
- Sponsor
- Christopher Rumley
- Enrollment
- 25
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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