Status:
RECRUITING
Partial Prostate Salvage High Dose Rate Brachytherapy
Lead Sponsor:
British Columbia Cancer Agency
Conditions:
Recurrent Prostate Cancer
Eligibility:
MALE
45+ years
Phase:
NA
Brief Summary
A dose-response relationship for radiation in the management of prostate cancer is well established. Local recurrence of prostate cancer after external beam radiotherapy occurs in at least 40% of pati...
Detailed Description
Appropriately selected patients with histologically documented recurrence 3 years or more after initial external beam radiotherapy will undergo mpMRI for identification of the site of recurrence. A pl...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
- Not compliant with criteria above
- Unable to give informed consent
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2037
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03246802
Start Date
January 1 2018
End Date
January 1 2037
Last Update
March 13 2025
Active Locations (1)
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1
BCCA Center for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3