5500/20 vs. SABR or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment (PROMPT)

Summary

We will investigate whether ultrahypofractionation using stereotactic ablative radiotherapy (SABR) or brachytherapy is as well-tolerated as moderately hypofractionated external beam radiotherapy (EBRT) for treating the prostate in patients with oligometastatic prostate cancer. Secondary aims include assessment of progression-free survival (PFS) and overall survival (OS) as well as cost-effectiveness. We hypothesize that ultrahypofractionation will maintain favorable toxicity profiles and quality of life while achieving comparable or better efficacy, thereby providing a convenient and cost-effective alternative to moderately hypofractionated EBRT.

Eligibility

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
* Able to complete the necessary investigations prior to randomization (History and physical examination, PSA)
* Able to complete the necessary investigations prior to start of Radiotherapy (Transrectal ultrasound-guided biopsy or equivalent, CT chest, abdomen \& pelvis or MRI abdomen and pelvis, and Bone scan)
* Planned for long-term androgen deprivation therapy (greater than 9 months in duration)
* Patient is able and willing to complete the quality of life questionnaires, and other assessments that are a part of this study

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

Contraindications to brachytherapy including:

* Medically unfit for anesthesia,
* International Prostate Symptom Score (IPSS) greater than 20
* Poor urinary flow 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

Conditions2

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