Delight: Combined LDR Boost and HDR Whole Gland

Sponsor

Sunnybrook Health Sciences Centre (Other)

Overall Status

Terminated

CT.gov ID

NCT03323879

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma Prostate	Radiation: LDR/HDR	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Intervention Model Description:

Sequential dose escalation designSequential dose escalation design

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Dominant Intraprostatic Lesion Boost With Focused LDR Brachytherapy (BT) Integrated to Whole Prostate HDR BT: Safety and Feasibility Analysis

Actual Study Start Date :

Oct 30, 2017

Actual Primary Completion Date :

Jul 1, 2020

Actual Study Completion Date :

Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Radiation: LDR/HDR Focal LDR to dominant lesion with whole gland 19 Gy HDR

Arm

Intervention/Treatment

Experimental: 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

Radiation: LDR/HDR

Focal LDR to dominant lesion with whole gland 19 Gy HDR

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sunnybrook Odette Cancer Centre	Toronto	Ontario	Canada	M4N3M5

Sponsors and Collaborators

Sunnybrook Health Sciences Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sunnybrook Health Sciences Centre

ClinicalTrials.gov Identifier:

NCT03323879

Other Study ID Numbers:

DELIGHT

First Posted:

Oct 27, 2017

Last Update Posted:

Apr 27, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sunnybrook Health Sciences Centre

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Apr 27, 2021