Potency pReservation In Prostate cAncer Patients Treated With UltraSound-guided Low-dose Rate Brachytherapy

Launched by LONDON HEALTH SCIENCES CENTRE RESEARCH INSTITUTE OR LAWSON RESEARCH INSTITUTE OF ST. JOSEPH'S · Jan 19, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat prostate cancer using a technique called Low-Dose Rate (LDR) brachytherapy, which involves placing small radioactive seeds in the prostate. The goal is to use advanced imaging technology, specifically Magnetic Resonance (MR) fusion with 3D Ultrasound, to help doctors avoid damaging important nerves and blood vessels near the prostate. This is important because it aims to preserve sexual function while still effectively treating the cancer.

To participate in this study, men between the ages of 65 and 75 with a specific type of prostate cancer (known as adenocarcinoma) that is classified as low or favorable intermediate risk may be eligible. They should also have good erectile function and be sexually active. Participants will receive the LDR brachytherapy treatment and will be closely monitored throughout the process. It’s important to note that certain health conditions and previous treatments could disqualify someone from joining the trial, so a thorough review will be done to determine eligibility.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Biopsy-confirmed adenocarcinoma of the prostate
• • NCCN-defined low- or favourable intermediate-risk prostate cancer patients
• • All pathological cores confined to one lobe of the prostate (minimum of 12 cores sampled), unless a recent multiparametric prostate MR-scan (mpMR) (with \< 6 months from the enrollment date) indicates a dominant intra-prostatic lesion (DIL) located at the prostatic lobe where a higher number of cores and Gleason score was found positive. PIRADS v2 score 3-5 lesions are considered DILs.
• • No or mild erectile function impairment (score ≥18 in International Index of Erectile Function- 5 \[IIEF-5\] without PDE-5 inhibitor assistance)
• • Sexually active
• • No contraindications to prostate LDR brachytherapy
• Exclusion Criteria:
• • Core positivity in both lobes of the prostate with no DIL detected on mpMR
• • mpMR suggesting presence of DILs in both lobes of the prostate
• • Contraindications to receiving a MR-scan
• • Medically unfit for general and/or spinal anesthesia
• • IPSS score \> 15
• • Inflammatory bowel disease
• • Prior abdominal-perineal resection
• • Presence of distant metastases and/or nodal disease
• • Older than 75 years of age
• • Use of cytoreductive prostate treatment (including 5 alpha-reductase inhibitors)
• • NCCN-defined unfavourable intermediate or high-risk prostate cancer
• • Signs of extra-capsular extension or seminal vesicle involvement on MR-scan
• • Prior TURP
• • \> 3mm of median lobe protrusion to bladder measured in mpMR (Roeloffzen 2011)
• • Prior RT to the pelvis
• • Significant artifact on MR-Scan (e.g. caused by hip prosthesis)