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

RECRUITINGN/ASponsored by British Columbia Cancer Agency
Actively Recruiting
PhaseN/A
SponsorBritish Columbia Cancer Agency
Started2021-07-12
Est. completion2030-06-30
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted

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

Age: 18 Years+Sex: MALEHealthy volunteers accepted
Inclusion Criteria:

* Signed study specific informed consent
* European Cooperative Oncology Group performance status 0 to 2
* Histologically confirmed adenocarcinoma of the prostate
* Any Tumor stage, any T, any N, M1
* No prior therapy for prostate cancer apart from androgen deprivation
* 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
* For brachytherapy arms, patient must be technically suitable for brachytherapy according to investigator, in terms of bladder function and prostate size.

Exclusion Criteria:

* High metastatic burden defined as 5 or more bone metastases or visceral metastases
* Contraindications to EBRT such as active inflammatory bowel disease or previous pelvic radiation
* For Brachytherapy Arms =: Any prior Transurethral resection of prostate

Conditions2

CancerOligometastatic Prostate Cancer

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