Combined LDR Boost and HDR Whole Gland (Delight)

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

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.

Study Overview

• Status: Terminated
• Conditions: Carcinoma Prostate
• Intervention / Treatment: Radiation: LDR/HDR

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N3M5
      • Sunnybrook Odette Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3-monthly for first year, then 6-monthly until Year 5
Health related quality of life (HRQOL) changes	Changes in HRQOL as assessed using Expanded Prostate Index Composite (EPIC)	3 monthly for first year, then annually year 1-5
Disease Free Survival	biochemical disease-free survival using PSA nadir + 2 ng/ml definition (Phoenix)	will be reported at 5 years

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2017
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: September 12, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 27, 2017

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 23, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: monotherapy; brachytherapy; LDR; HDR; focal
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: DELIGHT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No