Partial Prostate Salvage High Dose Rate Brachytherapy

Launched by BRITISH COLUMBIA CANCER AGENCY · Aug 8, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called High Dose Rate (HDR) brachytherapy for men with recurrent prostate cancer. After initial treatment with external beam radiotherapy, some patients may experience a return of cancer in the prostate. This trial aims to see if HDR brachytherapy can effectively target and treat the area of recurrence, with the hope that about half of the participants will remain cancer-free for five years.

To be eligible for this trial, participants need to be men over 45 years old who have had previous external beam radiotherapy, with a certain amount of time passed since their last treatment. They should also not have significant side effects from their previous treatment and need to have a specific kind of cancer recurrence that can be targeted. Participants can expect to undergo some imaging tests to precisely locate the cancer and then receive the HDR brachytherapy treatment. The trial is currently recruiting participants, and anyone considering joining should discuss it with their healthcare provider to understand the process and any potential risks or benefits.

Gender

MALE

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