None listed
Conditions
Brief summary
The study aims to evaluate the adverse events and quality of life outcomes associated with prostate stereotactic ablative radiotherapy (SABR) for newly diagnosed metastatic prostate cancer, Who is it for? You may be eligible to join this study if you are aged 18 years or above and have newly diagnosed metastatic prostate cancer. Study details: Traditional radiotherapy for de novo metastatic prostate cancer typically involves four weeks (20 sessions) of daily treatment to the prostate, on top of standard care systemic therapy. In this study, all participants in this study will receive SABR to the prostate delivered in five fractions, one fraction per week over 5 weeks, for a total of 35 Gy, in addition to standard care systemic therapy. Participants will complete questionnaires, and blood tests during regular follow-up visits up to 5 years post-SABR completion to determine quality of life and efficacy outcomes, and adverse events. It is hoped this study may provide evidence for a safe and effective, and more convenient radiation therapy schedule in the form of prostate SABR, for patients with metastatic prostate cancer.
Interventions
Patients will receive stereotactic ablative body radiotherapy (SABR) to the prostate delivered in five fractions, one fraction per week. Each SABR session will take approximately 30 minutes, This study will aim to deliver 5-fraction prostate SABR 35 GY in 5 fractions to the prostate.
SABR will be prescribed by treating radiation oncologist. Adherence to the intervention will be assessed by review of medical records.
All participants will be on standard care systemic therapy which is an eligib
Patients will receive stereotactic ablative body radiotherapy (SABR) to the prostate delivered in five fractions, one fraction per week. Each SABR session will take approximately 30 minutes, This study will aim to deliver 5-fraction prostate SABR 35 GY in 5 fractions to the prostate. SABR will be prescribed by treating radiation oncologist. Adherence to the intervention will be assessed by review of medical records. All participants will be on standard care systemic therapy which is an eligibility criteria for the trial, which typically includes androgen deprivation therapy +/- androgen receptor pathway inhibitor. The systemic therapy agent, dose, frequency and administration is dependent on that prescribed by the clinician. The timing of standard care systemic therapy relative to SABR delivery, i.e before or after radiotherapy, will be determined by treating clinicians and independent of patient’s enrolment in the current trial.
Sponsors
Alfred Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Histologically confirmed prostate adenocarcinoma. - Evidence of metastatic disease (M1a/b/c) on prostate specific membrane antigen positron emission tomography (PSMA PET) or CT/ bone scan staging - Metastatic prostate cancer at initial diagnosis (de novo) - Age 18 or over - ECOG 0-2 - Fit for (and commenced/ planned for) optimal systemic therapy including continuous androgen deprivation therapy +/- androgen receptor pathway inhibitors +/- chemotherapy - Capacity to consent to treatment and comply with radiation therapy treatment, follow-up schedule and completion of QOL questionnaires
Exclusion criteria
- Prior definitive prostate cancer treatment (prostatectomy and/ or prostate radiotherapy) - Prior pelvic radiotherapy - Contraindication for magnetic resonance imaging
Outcome results
None listed