Combined LDR Boost and HDR Whole Gland

Phase 1

Terminated

• Conditions: Carcinoma Prostate
• Interventions: Radiation: LDR/HDR

• Registration Number: NCT03323879
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

This is a dose finding Phase I/II study of combined focused LDR brachytherapy boost with whole gland single fraction HDR for men with low and intermediate risk prostate cancer and Dominant Intraprostatic Lesion (DIL) visible on multi parametric MRI. Patients will receive 19 Gy HDR to the whole gland with concurrent LDR brachytherapy boost to the DIL, in a sequential dose escalation manner. Primary endpoints are early toxicity.

Detailed Description

Eligible patients will have low and intermediate risk prostate cancer with a dominant intraprostatic lesion definable on multi parametric MRI (PIRADS 4 or 5). Patients will have MR planned LDR focal brachytherapy to the DIL using iodine-125, while at the same time have single 19 Gy delivered to the whole prostate using ultrasound directed high dose-rate brachytherapy (HDR). The LDR boost dose will start at 50 Gy, and increase DIL dose in sequential cohorts of patients up until a dose of 80 Gy. Up to 20 patients will be included. Primary endpoint is toxicity at 3 months.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-09-12
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-27
• Study Start: 2017-10-30
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-23
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 7

Inclusion Criteria

• Confirmed Adenocarcinoma of the prostate
• Single PIRADS 4 or 5 lesion on multiparametric MRI
• T1c-T2b on rectal exam
• Gleason 3+3 and PSA < 20ng/mL
• Gleason 3+4 and PSA <10ng/mL
• Less than 50% of the cores positive in an untargeted prostate biopsy.
• Prostate volume < 60 cc

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Exclusion Criteria

• Incapable or ineligible for MRI imaging
• Previous trans-urethral resection of prostate (TURP)
• Previous or current use of androgen deprivation
• Baseline International Prostate Symptom Score (IPSS) > 15
• Evidence of distant or nodal metastasis
• Disease that contraindicates treatment with radiation (e.g connective tissue disease)
• Unsuitable for anesthesia due to comorbidity

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LDR/HDR	LDR/HDR	MRI planned LDR boost to DIL with concurrent whole gland 19 Gy HDR. LDR dose will be sequentially escalated from 50 Gy to 80 Gy

Primary Outcome Measures

Name	Time	Method
Acute urinary and rectal toxicity at 3 months as measured using NCI CTCAE v 4.0	At 3 months	Acute urinary and rectal toxicity within the first 3 months as measured using NCI CTCAE v4.0

Secondary Outcome Measures

Name	Time	Method
Late urinary and rectal toxicity using NCI CTCAE v4.0	3-monthly for first year, then 6-monthly until Year 5	Cumulative incidence of urinary and rectal toxicity beyond 3 months using NCI CTCAE v4.0.
Health related quality of life (HRQOL) changes	3 monthly for first year, then annually year 1-5	Changes in HRQOL as assessed using Expanded Prostate Index Composite (EPIC)
Disease Free Survival	will be reported at 5 years	biochemical disease-free survival using PSA nadir + 2 ng/ml definition (Phoenix)

Trial Locations

Locations (1)

Sunnybrook Odette Cancer Centre; 🇨🇦 Toronto, Ontario, Canada