Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT03246802
Eligibility 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
* 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 Criteria:
* Not compliant with criteria above
* Unable to give informed consent
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Study:
NCT03246802
Study Brief:
Protocol Section:
NCT03246802