Combined LDR Boost and HDR Whole Gland

Carcinoma Prostate Clinical Trial

— Delight  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03323879
• Other study ID #: DELIGHT
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: October 30, 2017
• Est. completion date: July 1, 2020

Study information

• Verified date: April 2021
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma Prostate
• Prostatic Neoplasms

Intervention

Radiation:
• LDR/HDR
Focal LDR to dominant lesion with whole gland 19 Gy HDR

Locations

Country	Name	City	State
Canada	Sunnybrook Odette Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Disease Free Survival	biochemical disease-free survival using PSA nadir + 2 ng/ml definition (Phoenix)	will be reported at 5 years