Recruiting

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

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT04718987

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Low dose rate (LDR) brachytherapy

Study Details

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 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.

Conditions

Prostate Cancer

Study ID

NCT04718987

Start date

Jun 1, 2021

Status verified date

May, 2022

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Prostate Cancer Patients

Low- or favourable intermediate-risk prostate cancer patients

Interventions

Low dose rate (LDR) brachytherapy

Low dose rate (LDR) brachytherapy is a type of radiation treatment where doctor places the radioactive implants (seeds) inside patient's prostate gland and these seeds emits low dose radiation over a certain period of time. During low-dose-rate brachytherapy, a continuous low dose of radiation is released over time -from several hours to several days.

Primary outcome measure

Rate of patients receiving this experimental brachytherapy technique and achieving acceptable dose distribution at 1-month post-implant. [ Time Frame: 1 month after intervention ]

Central Contacts and Locations

Central contacts

Robin Sachdeva, PhD

519-685-8500 robin.sachdeva@lhsc.on.ca

Locations

London Regional Cancer Program

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Robin Sachdeva, PhD

519-685-8500 robin.sachdeva@lhsc.on.ca

Principal Investigator:

Lucas Mendez, MD, PhD

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

May 17, 2022

Last verified

May, 2022

Keywords

Brachytherapy
Radiation
Low Dose Rate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2022-05-17.