Status:
UNKNOWN
Potency pReservation In Prostate cAncer Patients Treated With UltraSound-guided Low-dose Rate Brachytherapy
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Prostate Cancer
Eligibility:
MALE
18-75 years
Phase:
NA
Brief Summary
The 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 neurovas...
Detailed Description
Low dose rate (LDR) brachytherapy is an excellent treatment strategy for patients with prostate confined cancers, achieving high curative rates. However, LDR brachytherapy has been linked with long-te...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04718987
Start Date
June 1 2021
End Date
December 1 2025
Last Update
May 17 2022
Active Locations (1)
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1
London Regional Cancer Program
London, Ontario, Canada, N6A 5W9