Potency pReservation In Prostate cAncer Patients Treated With UltraSound-guided Low-dose Rate Brachytherapy
Prostate CancerThe purpose of this study is to develop and evaluate a Magnetic Resonance (MR) fusion 3D Ultrasound (US) guided Low dose rate (LDR) brachytherapy technique that significantly spares prostatic neurovascular bundles (a bundle of nerves and vessels that run beside the prostate) and penile bulb (base of the penis), while still trying to effectively treat the prostate cancer.
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Participation Requirements
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Sex:
MALE -
Eligible Ages:
18 to 75
Participation 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)
Study Location
London Regional Cancer Program
London Regional Cancer ProgramLondon, Ontario
Canada
Contact Study Team
- Study Sponsored By
- London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
- Participants Required
- More Information
- Study ID:
NCT04718987