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

Oligometastatic Prostate Cancer

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.

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Participation Requirements

  • Sex:

    MALE
  • Eligible Ages:

    18 and up

Participation 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)
* Able to complete the necessary investigations priOr to start of Radiotherapy (Transrectal ultrasound-guided biopsy, CT chest, abdomen \& pelvis or MRI abdomen and pelvis, and 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

Study Location

Vancouver Cancer Center
Vancouver Cancer Center
Vancouver, British Columbia
Canada

Contact Study Team

Primary Contact

Mira Keyes, MD

[email protected]
604-266-6444
Fraser Valley Cancer Center
Fraser Valley Cancer Center
Surrey, British Columbia
Canada

Contact Study Team

Primary Contact

Winkle Kwan, MD

[email protected]
Vancouver Island Cancer Center
Vancouver Island Cancer Center
Victoria, British Columbia
Canada

Contact Study Team

Primary Contact

Saibishkumar Elantholi Parmeswaran, MD

[email protected]
British Columbia Cancer Agency Center for the Southern Interior
British Columbia Cancer Agency Center for the Southern Interior
Kelowna, British Columbia
Canada

Contact Study Team

Primary Contact

Juanita Crook, MD

[email protected]
250 712 3958
Study Sponsored By
British Columbia Cancer Agency
Participants Required
More Information
Study ID: NCT04610372