None listed
Conditions
Brief summary
The study aims to assess if salvage reirradiation with stereotactic ablative body radiation therapy (SABR) is a safe and feasible management option for locally recurrent prostate cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have locally recurrent prostate cancer following prior radiotherapy to the prostate. Study details: All participants will receive prostate SABR reirradiation (over 5 fractions) and 6 months of ADT. At baseline, participants will require imaging, blood tests, and questionnaire completion. Further blood tests will be required every 6 months up to 5 years post treatment, and at 2 years, some participants will require a further biopsy while all participants will require MRI. The findings will help guide clinicians on whether prostate SABR re-irradiation is a safe and effective option for this group of patients who currently have limited evidence-based local salvage treatment options.
Interventions
Patients will receive salvage reirradiation Stereotactic Ablative Radiotherapy (SABR) to the prostate, 35Gy in 5 fractions, one fraction per week, with rectal spacer.
Each fraction will take approximately 15 minutes. Adherence to the intervention will be assessed using review of medical records.
All patients will also receive a 6-month course of Androgen Deprivation Therapy (ADT) starting concurrently with their radiotherapy. ADT agent used will be Goserelin 10.8mg, two injections given 3 mont
Patients will receive salvage reirradiation Stereotactic Ablative Radiotherapy (SABR) to the prostate, 35Gy in 5 fractions, one fraction per week, with rectal spacer. Each fraction will take approximately 15 minutes. Adherence to the intervention will be assessed using review of medical records. All patients will also receive a 6-month course of Androgen Deprivation Therapy (ADT) starting concurrently with their radiotherapy. ADT agent used will be Goserelin 10.8mg, two injections given 3 monthly (each administered over < 1 minute), and medical records will be reviewed to assess adherence.
Sponsors
Alfred Health
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 locally recurrent prostate cancer - Recurrence at least 2 years after completion of previous curative intent definitive prostate radiation therapy (2 years from end date of androgen deprivation therapy if androgen deprivation therapy was given with prostate radiation therapy) - Able to undergo pre-treatment multiparametric magnetic resonance imaging (mpMRI) and prostate specific membrane antigen positron emission tomography/ computed tomography (PSMA-PET/CT) - Capacity to consent to treatment and comply with follow-up schedule and completion of toxicity and QOL questionnaires
Exclusion criteria
- Poor baseline urinary function (IPSS>20) - Contraindication to MRI or PSMA-PET/CT - Contraindication to gold-fiducial insertion or rectal spacer insertion - Anticoagulation medication use (that is unsafe to be discontinued for fiducial marker and rectal spacer insertion) - Bleeding diathesis (that is unsafe for fiducial marker and rectal spacer insertion) - Evidence of pelvic nodal disease or distant metastasis on PSMA-PET/CT - Prior ultra-hypofractionated radiation therapy (>5 Gy/ fraction) - Castrate resistant prostate cancer – defined as PSA >3 ng/ml while testosterone <0.7nmol/l)
Outcome results
None listed