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Combined LDR Boost and HDR Whole Gland (Delight)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03323879
Recruitment Status : Terminated (Slow accrual)
First Posted : October 27, 2017
Last Update Posted : April 27, 2021
Information provided by (Responsible Party):
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.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: Sequential 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 : October 30, 2017
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Acute urinary and rectal toxicity at 3 months as measured using NCI CTCAE v 4.0 [ Time Frame: At 3 months ]
    Acute urinary and rectal toxicity within the first 3 months as measured using NCI CTCAE v4.0

Secondary Outcome Measures :
  1. Late urinary and rectal toxicity using NCI CTCAE v4.0 [ Time Frame: 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.

  2. Health related quality of life (HRQOL) changes [ Time Frame: 3 monthly for first year, then annually year 1-5 ]
    Changes in HRQOL as assessed using Expanded Prostate Index Composite (EPIC)

  3. Disease Free Survival [ Time Frame: will be reported at 5 years ]
    biochemical disease-free survival using PSA nadir + 2 ng/ml definition (Phoenix)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03323879

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Canada, Ontario
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada, M4N3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
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Responsible Party: Sunnybrook Health Sciences Centre Identifier: NCT03323879    
Other Study ID Numbers: DELIGHT
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sunnybrook Health Sciences Centre:
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases