NCT03323879: Delight

Combined LDR Boost and HDR Whole Gland

Terminated Phase 1, PHASE2 Last updated 27 April 2021

What this trial tests

Phase 1, PHASE2 trial testing LDR/HDR in Carcinoma Prostate in 7 participants. Terminated before completion.

Timeline

30 October 2017

Primary endpoint
1 July 2020

1 July 2020

Quick facts

Lead sponsor	Sunnybrook Health Sciences Centre
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	30 October 2017
Primary completion	1 July 2020
Estimated completion	1 July 2020
Sites	1 location across Canada

Drugs / interventions tested

• LDR/HDR

Conditions studied

• Carcinoma Prostate — all drugs for Carcinoma Prostate →

Sponsor

Sunnybrook Health Sciences Centre — full company profile →

Who can join

18 and older, male only, with Carcinoma Prostate. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Analysis of outcomes after non-contour-based dose painting of dominant intra-epithelial lesion in intra-operative low-dose rate brachytherapy.
   Martell K, Roy S, Meyer T, Stosky J, et al · · 2020 · cited 1× · PMID 32548323 · DOI 10.1016/j.heliyon.2020.e04092