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

NCT04718987 | Unknown

• 1 other identifier: PRIAPUS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Brachytherapy; Radiation; Low Dose Rate

Outcome Measures

Primary Outcomes (1)

• Rate of patients receiving this experimental brachytherapy technique and achieving acceptable dose distribution at 1-month post-implant.

  Acceptable dose distribution is defined as: 1. Target volume (Prostate, excluding a 5 mm expansion of the Neurovascular bundle) D90 ≥ 140 Gy 2. Contralateral neurovascular bundle median dose ≤ 50 Gy 3. Prostatic bulb D10 dose ≤ 50 Gy (Chasseray 2019) 4. Urethra D30 \< 130% of the prescription dose

  1 month after intervention

Secondary Outcomes (5)

• Number of patient with preserved erectile function Erectile Function (IIEF) >= 18)

  1, 6, 12, 18, 24, 36, 48, 60 months post intervention

• Post-procedure PSA dynamic

  6, 12, 18, 24, 36, 48, 60 months post intervention

• Acute and long-term GU and GI toxicity

  1, 6, 12, 18, 24, 36, 48, 60 months post intervention

• Biochemical failure

  1, 6, 12, 18, 24, 36, 48, 60 months post intervention

• Local recurrence

  Until study completion with 5 years of follow up

Study Arms (1)

Prostate Cancer Patients

EXPERIMENTAL

Low- or favourable intermediate-risk prostate cancer patients

Radiation: Low dose rate (LDR) brachytherapy

Interventions

Low dose rate (LDR) brachytherapy RADIATION

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.

Prostate Cancer Patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Male only because this study trying to preserve the Penis erection in patients undergoing Radiation treatment for their prostate cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

London Regional Cancer Program

London, Ontario, N6A 5W9, Canada

RECRUITING

Related Publications (6)

• Mulhall J, Ahmed A, Parker M, Mohideen N. The hemodynamics of erectile dysfunction following external beam radiation for prostate cancer. J Sex Med. 2005 May;2(3):432-7. doi: 10.1111/j.1743-6109.2005.20362.x.

  PMID: 16422876 BACKGROUND

• Mabjeesh N, Chen J, Beri A, Stenger A, Matzkin H. Sexual function after permanent 125I-brachytherapy for prostate cancer. Int J Impot Res. 2005 Jan-Feb;17(1):96-101. doi: 10.1038/sj.ijir.3901271.

  PMID: 15510186 BACKGROUND

• Putora PM, Engeler D, Haile SR, Graf N, Buchauer K, Schmid HP, Plasswilm L. Erectile function following brachytherapy, external beam radiotherapy, or radical prostatectomy in prostate cancer patients. Strahlenther Onkol. 2016 Mar;192(3):182-9. doi: 10.1007/s00066-015-0928-x. Epub 2015 Dec 28.

  PMID: 26713323 BACKGROUND

• Chasseray M, Dissaux G, Bourbonne V, Boussion N, Goasduff G, Malloreau J, Malhaire JP, Fournier G, Tissot V, Pradier O, Valeri A, Schick U. Dose to the penile bulb and individual patient anatomy are predictive of erectile dysfunction in men treated with 125I low dose rate brachytherapy for localized prostate cancer. Acta Oncol. 2019 Jul;58(7):1029-1035. doi: 10.1080/0284186X.2019.1574981. Epub 2019 Feb 14.

  PMID: 30761939 BACKGROUND

• Sun Y, Qiu W, Yuan J, Romagnoli C, Fenster A. Three-dimensional nonrigid landmark-based magnetic resonance to transrectal ultrasound registration for image-guided prostate biopsy. J Med Imaging (Bellingham). 2015 Apr;2(2):025002. doi: 10.1117/1.JMI.2.2.025002. Epub 2015 Jun 24.

  PMID: 26158111 BACKGROUND

• Crook JM, Gomez-Iturriaga A, Wallace K, Ma C, Fung S, Alibhai S, Jewett M, Fleshner N. Comparison of health-related quality of life 5 years after SPIRIT: Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial. J Clin Oncol. 2011 Feb 1;29(4):362-8. doi: 10.1200/JCO.2010.31.7305. Epub 2010 Dec 13.

  PMID: 21149658 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Lucas Mendez, MD

  London Health Sciences Centre- London Regional Cancer Program

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robin Sachdeva, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-arm clinical trial to enroll a total of 10 low- or favourable intermediate-risk prostate cancer patients.

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: January 22, 2021
• Study Start: June 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2025
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)