Back to resultsCombined LDR Boost and HDR Whole Gland (Delight)
Primary Purpose
Carcinoma Prostate
Status
Terminated
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
LDR/HDR
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma Prostate focused on measuring brachytherapy, LDR, HDR, monotherapy, focal
Eligibility Criteria
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
Sites / Locations
- Sunnybrook Odette Cancer Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LDR/HDR
Arm Description
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
Outcomes
Primary Outcome Measures
Acute urinary and rectal toxicity at 3 months as measured using NCI CTCAE v 4.0
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
Cumulative incidence of urinary and rectal toxicity beyond 3 months using NCI CTCAE v4.0.
Health related quality of life (HRQOL) changes
Changes in HRQOL as assessed using Expanded Prostate Index Composite (EPIC)
Disease Free Survival
biochemical disease-free survival using PSA nadir + 2 ng/ml definition (Phoenix)
Full Information
NCT ID
NCT03323879
First Posted
September 12, 2017
Last Updated
April 23, 2021
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT03323879
Brief Title
Combined LDR Boost and HDR Whole Gland
Acronym
Delight
Official Title
Dominant Intraprostatic Lesion Boost With Focused LDR Brachytherapy (BT) Integrated to Whole Prostate HDR BT: Safety and Feasibility Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma Prostate
Keywords
brachytherapy, LDR, HDR, monotherapy, focal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Sequential dose escalation design
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LDR/HDR
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
LDR/HDR
Intervention Description
Focal LDR to dominant lesion with whole gland 19 Gy HDR
Primary Outcome Measure Information:
Title
Acute urinary and rectal toxicity at 3 months as measured using NCI CTCAE v 4.0
Description
Acute urinary and rectal toxicity within the first 3 months as measured using NCI CTCAE v4.0
Time Frame
At 3 months
Secondary Outcome Measure Information:
Title
Late urinary and rectal toxicity using NCI CTCAE v4.0
Description
Cumulative incidence of urinary and rectal toxicity beyond 3 months using NCI CTCAE v4.0.
Time Frame
3-monthly for first year, then 6-monthly until Year 5
Title
Health related quality of life (HRQOL) changes
Description
Changes in HRQOL as assessed using Expanded Prostate Index Composite (EPIC)
Time Frame
3 monthly for first year, then annually year 1-5
Title
Disease Free Survival
Description
biochemical disease-free survival using PSA nadir + 2 ng/ml definition (Phoenix)
Time Frame
will be reported at 5 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sunnybrook Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Combined LDR Boost and HDR Whole Gland
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