High dose rate brachytherapy for recurrent prostate cancer
High Dose Rate Partial Prostate Brachytherapy as Salvage Treatment for Local Failures After Previous External Beam Radiotherapy
This study is testing if a special type of radiation therapy can help men with recurrent prostate cancer feel better and control their cancer after previous treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 45 Years and up |
| Sex | Male |
| Sponsor | British Columbia Cancer Agency Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Kelowna, British Columbia) |
| Trial ID | NCT03246802 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of high dose rate (HDR) brachytherapy as a salvage treatment for patients with recurrent prostate cancer following external beam radiotherapy. Patients with documented recurrence will undergo advanced imaging using multiparametric MRI to identify the site of recurrence, followed by a planning ultrasound to create a targeted treatment plan. The treatment involves delivering two fractions of HDR brachytherapy, with careful monitoring of patient outcomes, including toxicity and quality of life, over a two-year period. The study aims to evaluate the efficacy of this approach in achieving long-term cancer control.
Who should consider this trial
Good fit: Ideal candidates are men over 45 years old with a life expectancy of more than 10 years and a documented recurrence of prostate cancer at least three years after initial treatment.
Not a fit: Patients with severe late toxicity from prior treatments or those with multiple areas of recurrence may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the chances of remaining cancer-free for patients with recurrent prostate cancer.
How similar studies have performed: While there is extensive literature on low dose rate salvage brachytherapy, the use of high dose rate brachytherapy for this indication is less explored, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>45 and Life expectancy \>10 years * Previous External Beam Radiotherapy (EBRT) dose up to 78Gray/39 fractions, 81 Gray/45 fractions or 70 Gray/28 fractions or LDR brachytherapy with site of recurrence in an under-dosed or untreated site * \> 3 year interval since EBRT or LDR Brachytherapy * No late toxicity from prior EBRT ≥ grade 2 * Rising PSA post EBRT \> nadir + 2 ng/ml but \< 10 ng/ml * PSA Doubling time \> 6 months * Negative staging with CT scan of the abdomen/pelvis and bone scan (PSMA PET scan can replace CT and bone scan) * Able to undergo multiparametric MRI with endorectal coil * Radiographic evidence of dominant intraprostatic lesion (DIL) as only area of recurrence (i.e unifocal recurrence) and corresponding to site of original disease * Biopsy confirmation of DIL with pathology review by British Columbia Cancer Agency GenitoUrinary pathologist (TB) * Willing to provide informed consent * History and physical examination within 90 days of registration * ECOG performance status 0-1 prior to registration * IPSS \< 16, or adequate voiding study (post void residual \< 100cc and peak flow rate \> 10 cc/second). * No prior trans urethral prostatic resection * Recurrence suitable for implant with HDR brachytherapy as assessed on ultrasound simulation (maximum PTV ideally \< 65% of prostate volume) * No history of inflammatory bowel disease or previous rectal surgery * Suitable for procedure under anesthesia, spinal or general * INR \<2.5 and platelet count \>75 x 109/L * Androgen Deprivation Therapy may be initiated at the discretion of the treating oncologist Exclusion Criteria: * Not compliant with criteria above * Unable to give informed consent
Where this trial is running
Kelowna, British Columbia
- BCCA Center for the Southern Interior — Kelowna, British Columbia, Canada (Recruiting)
Study contacts
- Study coordinator: Juanita Crook, MD
- Email: jcrook@bccancer.bc.ca
- Phone: 2507123958
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.