New technique for prostate cancer treatment using ultrasound-guided brachytherapy
Potency pReservation In Prostate cAncer Patients Treated With UltraSound-guided Low-dose Rate Brachytherapy
NA · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · NCT04718987
This study is testing a new ultrasound-guided treatment for localized prostate cancer to see if it can effectively treat the cancer while causing less long-term erectile dysfunction.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Male |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT04718987 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and evaluate a Magnetic Resonance (MR) fusion 3D Ultrasound (US) guided Low Dose Rate (LDR) brachytherapy technique that minimizes damage to surrounding neurovascular bundles and the penile bulb while effectively treating prostate cancer. The approach focuses on patients with localized prostate cancer, aiming to reduce the incidence of long-term erectile dysfunction associated with traditional brachytherapy methods. By utilizing advanced imaging techniques, the study seeks to enhance treatment precision and patient outcomes. Participants will undergo LDR brachytherapy, with careful monitoring of erectile function post-treatment.
Who should consider this trial
Good fit: Ideal candidates include men with biopsy-confirmed adenocarcinoma of the prostate who have low- or favorable intermediate-risk disease and no significant erectile dysfunction.
Not a fit: Patients with prostate cancer that has spread to both lobes or those with contraindications to MR-scans may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could significantly reduce the risk of erectile dysfunction in prostate cancer patients undergoing treatment.
How similar studies have performed: While LDR brachytherapy has been established as an effective treatment, this specific MR fusion 3D ultrasound-guided approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
London, Ontario
- London Regional Cancer Program — London, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Lucas Mendez, MD — London Health Sciences Centre- London Regional Cancer Program
- Study coordinator: Robin Sachdeva, PhD
- Email: robin.sachdeva@lhsc.on.ca
- Phone: 519-685-8500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Brachytherapy, Radiation, Low Dose Rate