Does local recurrence of prostate cancer after radiation therapy occur at the site of primary tumor? Results of a longitudinal MRI and MRSI study.
Elnasif Arrayeh, Antonio C Westphalen, John Kurhanewicz...
https://pubmed.ncbi.nlm.nih.gov/22331003Actively Recruiting
Phase Not Applicable
Age: 45Years +
MALE
ID03246802
High Dose Rate Partial Prostate Brachytherapy as Salvage Treatment for Local Failures After Previous External Beam Radiotherapy
Led by British Columbia Cancer Agency · Updated on 2026-02-02
30
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of high dose rate (HDR) partial prostate brachytherapy as a salvage treatment for men with recurrent prostate cancer after initial external beam radiotherapy. This study focuses on patients who have a local recurrence identified by advanced imaging techniques, such as multiparametric MRI, allowing targeted treatment of the tumor site. The study investigates the safety and effectiveness of this approach, with a particular interest in late side effects and quality of life after treatment. Selected patients with biopsy-confirmed recurrence more than three years after initial radiotherapy will undergo imaging and ultrasound planning to define the treatment area. Two doses of HDR brachytherapy will be delivered to the targeted prostate region, two weeks apart, using temporary radioactive implants. The treatment volume includes the tumor plus a small margin, adjusted to protect nearby organs. Androgen deprivation therapy may also be used based on oncologist discretion. Participants will be monitored for toxicity and quality of life through questionnaires such as the Expanded Prostate Cancer Index and the International Prostate Symptom Score. Prostate specific antigen (PSA) levels and repeat MRI scans will be used to assess treatment effectiveness over two years. The primary outcome measure is the occurrence of severe late gastrointestinal or genitourinary side effects up to five years. The study started in 2018 and will continue to follow participants long term for safety and disease control.
CONDITIONS
Brief Title
Partial Prostate Salvage High Dose Rate Brachytherapy
Who Can Participate
Age: 45Years +
MALE
Eligibility Criteria
You may qualify if you...
- Male aged 45 years or older with life expectancy greater than 10 years
- Previous external beam radiotherapy (EBRT) or low dose rate brachytherapy with site of recurrence in an under-dosed or untreated area
- At least 3 years since initial EBRT or LDR brachytherapy
- No late toxicity from prior EBRT grade 2 or higher
- Rising PSA after EBRT greater than nadir + 2 ng/ml but less than 10 ng/ml
- PSA doubling time greater than 6 months
- Negative staging scans (CT abdomen/pelvis and bone scan or PSMA PET scan)
- Able to undergo multiparametric MRI with endorectal coil
- Radiographic evidence of unifocal dominant intraprostatic lesion corresponding to site of original disease
- Biopsy confirmation of tumor with pathology review
- Willing to provide informed consent
- History and physical exam within 90 days prior to registration
- ECOG performance status 0-1
- International Prostate Symptom Score less than 16 or adequate voiding study
- No prior transurethral prostatic resection
- Recurrence suitable for implant with HDR brachytherapy, with planning target volume ideally less than 65% of prostate volume
- No history of inflammatory bowel disease or previous rectal surgery
- Suitable for procedure under anesthesia
- INR less than 2.5 and platelet count greater than 75 x 10^9/L
- Androgen deprivation therapy may be started as decided by treating oncologist
You will not qualify if you...
- Not meeting all inclusion criteria
- Unable to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Up to 3 months prior to treatment
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Approximately 2 weeks
Participants receive two fractions of high dose rate partial prostate brachytherapy delivered to the site of recurrent disease, each from a single implant, two weeks apart.
2 treatment visits (in-person) spaced 2 weeks apart
Follow-up
Duration - Up to 5 years after treatment
Participants are monitored for toxicity and quality of life using questionnaires and for treatment efficacy by monitoring PSA and repeat mpMRI at 2 years.
Scheduled follow-up visits over several years including assessments at 2 years
Trial Site Locations
Total: 1 location
1
BCCA Center for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
Actively Recruiting
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Research Team
J
Juanita Crook, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
From whole gland to hemigland to ultra-focal high-dose-rate prostate brachytherapy: A dosimetric analysis.
Robyn Banerjee, Sang-June Park, Erik Anderson...
https://pubmed.ncbi.nlm.nih.gov/25680768Ultrasound-planned high-dose-rate prostate brachytherapy: dose painting to the dominant intraprostatic lesion.
Juanita Crook, Ana Ots, Miren Gaztañaga...
https://pubmed.ncbi.nlm.nih.gov/24958556A prospective comparison of MRI-US fused targeted biopsy versus systematic ultrasound-guided biopsy for detecting clinically significant prostate cancer in patients on active surveillance.
Michael R Da Rosa, Laurent Milot, Linda Sugar...
https://pubmed.ncbi.nlm.nih.gov/25044935Dosimetry modeling for focal high-dose-rate prostate brachytherapy.
Josh Mason, Bashar Al-Qaisieh, Peter Bownes...
https://pubmed.ncbi.nlm.nih.gov/25085456Salvage low-dose-rate permanent seed brachytherapy for locally recurrent prostate cancer: Association between dose and late toxicity.
Jim N Rose, Juanita M Crook, Tom Pickles...
https://pubmed.ncbi.nlm.nih.gov/25727178