Combined LDR Boost and HDR Whole Gland

Phase 2TerminatedNCT03323879

Sunnybrook Health Sciences Centre7 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma Prostate

Interventions

LDR/HDRRADIATION

Focal LDR to dominant lesion with whole gland 19 Gy HDR

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sunnybrook Odette Cancer Centre

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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

Time frame: At 3 months

Secondary Outcomes

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.

Time frame: 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)

Time frame: 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)

Time frame: will be reported at 5 years

Data from ClinicalTrials.gov

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