None listed
Conditions
Brief summary
This study is investigating the feasibility of delivering salvage re-irradiation to the prostate gland in men who have previously received radiation. Who is it for? You may be eligible for this trial if you are a male aged 18 years or over, have previously treated been treated for prostate cancer with external beam radiotherapy or brachytherapy and have a local recurrence within the prostate, with no more than 5 distant metastases. Study details Participants will receive radiation to the prostate gland using Magnetic Guided adaptive radiotherapy on the MRI linear accelerator. The intervention is intended to be delivered as 5 radiotherapy sessions over 2 weeks. Participants will be asked to provide 9 blood samples throughout the study to assess the response to treatment. Data on toxicity and prostate specific antigen (PSA) response to treatment will be collected. Information from this study will be used to determine whether a MRI-guided approach to radiotherapy is a feasible clinical approach for the treatment of recurrent prostate cancer.
Interventions
Repeat irradiation (re-irradiation) to recurrent tumour within the prostate gland, after prior radiotherapy or brachytherapy.
Treatment will be delivered on the Elekta Unity MRI-guided linear accelerator (MR-linac) using a dose of 34Gy in 5 fractions for those previously treated with external beam radiotherapy, or with brachytherapy if the recurrence is confined to the seminal vesicles. Patients with local recurrence within the prostate after brachytherapy will be treated to a dose of 30Gy in
Repeat irradiation (re-irradiation) to recurrent tumour within the prostate gland, after prior radiotherapy or brachytherapy. Treatment will be delivered on the Elekta Unity MRI-guided linear accelerator (MR-linac) using a dose of 34Gy in 5 fractions for those previously treated with external beam radiotherapy, or with brachytherapy if the recurrence is confined to the seminal vesicles. Patients with local recurrence within the prostate after brachytherapy will be treated to a dose of 30Gy in 5 fractions. Treatment will be delivered 2 or 3 times a week, and not on consecutive days. Overall treatment is anticipated to be completed within 2 weeks. Patients may be eligible for treatment if more than 2 years have elapsed between initial radiotherapy or brachytherapy and the detection of biochemical failure, provided other eligibility criteria are met. Treatment will be administered by radiation therapists, with daily plan adaptation under the supervision of the treating radiation oncologist, who will also be defining the target volume and surrounding normal organs at risk. Adherence to treatment will be monitored by review of daily radiotherapy treatment plans and the medical records at the completion of treatment.
Sponsors
Christopher Rumley
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed