None listed
Conditions
Brief summary
The study aims to evaluate the adverse events, quality of life and oncological outcomes associated with stereotactic ablative radiotherapy (SABR) to the prostate and all metastatic sites 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 newly diagnosed metastatic prostate cancer typically involves four weeks (20 sessions) of daily treatment to the prostate (without radiotherapy treatment to the metastatic sites), on top of standard care systemic therapy. In this study, all participants in this study will receive SABR to the prostate and all metastatic sites delivered in two fractions, one fraction per week over 2 weeks, for a total of 24 Gy, in addition to standard care systemic therapy. Participants will complete questionnaires, 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. There will also be one PSMA PET scan at 3 months post completion of SABR treatment. It is hoped this study may provide evidence for a safe and effective, and more convenient radiation therapy schedule in the form of SABR, for patients with metastatic prostate cancer.
Interventions
Patients will receive stereotactic ablative body radiotherapy (SABR) to the prostate and metastatic sites delivered in two fractions, one fraction per week. Each SABR session will take approximately 30 minutes, This study will aim to deliver 2-fraction SABR 24 Gy in 2 fractions to the prostate and metastatic sites.
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 syst
Patients will receive stereotactic ablative body radiotherapy (SABR) to the prostate and metastatic sites delivered in two fractions, one fraction per week. Each SABR session will take approximately 30 minutes, This study will aim to deliver 2-fraction SABR 24 Gy in 2 fractions to the prostate and metastatic sites. 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 and androgen receptor pathway inhibitor. The systemic therapy agent, dose, frequency and administration is dependent on that prescribed by the clinician. SABR treatment needs to be started within 90 days of commencement of systemic therapy
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 oligo-metastases (>10 nodal or bone metastases) on prostate specific membrane antigen positron emission tomography (PSMA PET) (M1a/ M1b), with no evidence of visceral metastases (M1c) - ECOG 0-2 - Life expectancy >12 months - Capacity to consent to treatment and comply with follow-up schedule and completion of QOL questionnaires
Exclusion criteria
- Serum PSA at diagnosis >100 ng/mL - Rare histological variant e.g. small cell carcinoma of prostate - Prostate volume >100cc (on diagnostic MRI) - cT4 disease (i.e. tumour fixed or invades adjacent structures other than seminal vesicles, such as external sphincter, rectum, bladder, levator muscle and/ or pelvic wall), or locally advanced primary disease deemed not amenable to SABR by the treating clinicians - Presence of visceral metastases (M1c) - Metastatic sites deemed not amenable to SABR by treating clinicians (e.g. unable to meet organs-at-risk dose constraints) - Contraindications for magnetic resonance imaging (MRI) - Prior pelvic radiation therapy - Severe obstructive lower urinary tract symptoms (International Prostate Symptom Score >20) - Bleeding diathesis or use of anti-coagulation that is unsafe to discontinue for fiducial marker - Comorbidities which predispose to significant radiation therapy adverse events (e.g., inflammatory bowel disease) - Pelvic metalwork (e.g. hip replacement) that may cause artefact on diffusion-weighted magnetic resonance imaging. - Contraindication for androgen deprivation therapy and androgen receptor pathway inhibitors (ARPI)
Outcome results
None listed