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Recruiting
NCT03246802
Partial Prostate Salvage High Dose Rate Brachytherapy
Conditions: Recurrent Prostate Cancer
Sex: Male
Ages: 45 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: British Columbia Cancer Agency
Location: BCCA Center for the Southern Interior Kelowna British Columbia
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 patients treated because of inability to deliver sufficient dose through external beam techniques. These patients respond well to re-irradiation using brachytherapy with about 50% of selected patients remaining free of recurrence 5 years after salvage. Advanced imaging using multiparametric Magnetic Resonance Imaging (mpMRI) allows identification of the site of recurrence, permitting partial prostate salvage brachytherapy. There is extensive literature on Low Dose Rate salvage brachytherapy but less on High Dose Rate.
Eligibility Criteria
Inclusion Criteria:
* Age \>45 and Life expectancy \>10 years
* Previous External Beam Radiotherapy (EBRT) or LDR brachytherapy w
* \> 3 year interval since EBRT or LDR Brachytherapy
* No late toxicity from prior EBRT ≥ grade 2
* PSA \> nadir + 2 ng/ml and \< 10 ng/ml
* PSA Doubling time \> 6 months
* Radiographic evidence corresponding with site of recurrence in an under-dosed or untreated site. The recurrence should correspond to the site of original disease or be located in the seminal vesical +/- adjacent prostate as only area of recurrence (i.e. unifocal recurrence).
* Per Investigator, recurrence is suitable for implant with HDR brachytherapy and patient is suitable for procedure under anesthesia, spinal or general.
* Negative staging of the abdomen/pelvis and bones.
* Willing to provide informed consent
Exclusion Criteria:
* Not compliant with criteria above
* Unable to give informed consent
Source: ClinicalTrials.gov (NCT03246802). StuddyBuddy aggregates publicly available trial information.