NCT04610372 5500/20 vs. SABR or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment (PROMPT)
| NCT ID | NCT04610372 |
| Status | Recruiting |
| Phase | — |
| Sponsor | British Columbia Cancer Agency |
| Condition | Oligometastatic Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2021-07-12 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 168 participants in total. It began in 2021-07-12 with a primary completion date of 2030-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Juanita Crook, MD
PRINCIPAL INVESTIGATOR
BCCancer
Frequently Asked Questions
Who can join the NCT04610372 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Oligometastatic Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04610372 currently recruiting?
Yes, NCT04610372 is actively recruiting participants. Contact the research team at jcrook@bccancer.bc.ca for enrollment information.
Where is the NCT04610372 trial being conducted?
This trial is being conducted at Kelowna, Canada, Surrey, Canada, Vancouver, Canada, Victoria, Canada.
Who is sponsoring the NCT04610372 clinical trial?
NCT04610372 is sponsored by British Columbia Cancer Agency. The principal investigator is Juanita Crook, MD at BCCancer. The trial plans to enroll 168 participants.
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