5500/20 vs. SABR or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment (PROMPT) (PROMPT)
Oligometastatic Prostate Cancer
About this trial
This is an interventional treatment trial for Oligometastatic Prostate Cancer focused on measuring prostate adenocarcinoma, oligometastases, radiotherapy, hypofractionation, brachytherapy
Eligibility Criteria
Inclusion Criteria:
- Able to provide informed consent
- European Cooperative Oncology Group performance status 0 to 2
- Medically fit for all protocol treatment and follow-up
- Histologically confirmed adenocarcinoma of the prostate
- Newly diagnosed any Tumor stage, any Nodal stage but with oligo metastases
- No prior therapy for prostate cancer apart from androgen deprivation
- Luteinizing Hormone Releasing Hormone (LHRH) agonists or antagonists must have started within 24 weeks of randomization
- If used, anti-androgens must have started within 26 weeks of randomization
- Able to complete the necessary investigations prior to and within 12 weeks of starting Androgen Deprivation Therapy (ADT) or of randomization (History and physical examination, PSA, Transrectal ultrasound-guided biopsy, CT or MRI abdomen and pelvis, Bone scan)
- Planned for long-term androgen deprivation therapy
Exclusion Criteria:
- High metastatic burden defined as 5 or more bone metastases or visceral metastases
- Abnormal liver function
- Contraindications to EBRT such as active inflammatory bowel disease or previous pelvic radiation
- Medically unfit for anesthesia
- International Prostate Symptom Score (IPSS) greater than 20
- Restrictive flow pattern with peak flow rate less than10 mL per second or post-void residual greater than 25 per cent of voided volume (when uroflowmetry available)
- Prostate volume greater than 60cc after maximal cytoreduction
- Pubic arch interference
- Transurethral resection of prostate (TURP) within 12 weeks of brachytherapy
Sites / Locations
- British Columbia Cancer Agency Center for the Southern InteriorRecruiting
- Fraser Valley Cancer Center
- Vancouver Cancer Center
- Vancouver Island Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Experimental
Experimental
standard
High dose rate brachytherapy
Permanent seed implant brachytherapy
Stereotactic body radiotherapy
External beam radiotherapy to deliver 5500 centiGray (cGy) in 20 fractions to the prostate over 4 weeks
A single fraction of 19 Gray (Gy) is delivered to the prostate under anesthesia as an out patient.
A single permanent implant of radioactive Iodine-125 seeds is performed under anesthesia as an out patient to deliver 125 Gy to the prostate
36.25 Gy is delivered to the prostate in 5 fractions given either weekly or every second day, using a SABR technique.