Comparing different radiation therapies for treating oligometastatic prostate cancer
Moderate Versus Ultra Hypofractionation or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment
This study is testing whether new types of radiation therapy can help men with oligometastatic prostate cancer feel better and live longer compared to standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 168 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | British Columbia Cancer Agency Academic / other |
| Drugs / interventions | radiation |
| Locations | 4 sites (Kelowna, British Columbia and 3 other locations) |
| Trial ID | NCT04610372 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness and tolerability of ultrahypofractionated stereotactic ablative radiotherapy (SABR) and brachytherapy compared to moderately hypofractionated external beam radiotherapy (EBRT) in men with oligometastatic prostate cancer. Participants will be randomized to receive one of the treatment options, and their urinary quality of life will be assessed alongside other secondary endpoints such as progression-free survival and overall survival. The trial aims to determine if the newer radiation techniques can provide similar or better outcomes while being more convenient and cost-effective.
Who should consider this trial
Good fit: Ideal candidates are men newly diagnosed with low volume oligometastatic prostate cancer, defined as fewer than 5 bone metastases and/or non-regional lymph node involvement.
Not a fit: Patients with a high metastatic burden, defined as 5 or more bone metastases or visceral metastases, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a more effective and less burdensome treatment option for patients with oligometastatic prostate cancer.
How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific comparison of ultrahypofractionation techniques is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kelowna, British Columbia and 3 other locations
- British Columbia Cancer Agency Center for the Southern Interior — Kelowna, British Columbia, Canada (Recruiting)
- Fraser Valley Cancer Center — Surrey, British Columbia, Canada (Not_yet_recruiting)
- Vancouver Cancer Center — Vancouver, British Columbia, Canada (Recruiting)
- Vancouver Island Cancer Center — Victoria, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Juanita Crook, MD — BCCancer
- Study coordinator: Juanita Crook, MD
- Email: jcrook@bccancer.bc.ca
- Phone: 250 712 3958
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.