Combined LDR Boost and HDR Whole Gland (Delight)

Sunnybrook Health Sciences Centre

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Carcinoma Prostate

Treatments: Radiation: LDR/HDR

Study type: Interventional

Funder types: Other

Identifiers

NCT03323879

DELIGHT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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7 participants in 1 patient group

LDR/HDR

Experimental group

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

Treatment:

Radiation: LDR/HDR