Combined LDR Boost and HDR Whole Gland

NCT ID: NCT03323879

Last Updated: 2021-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-30

Study Completion Date

2020-07-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carcinoma Prostate

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Sequential dose escalation design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

LDR/HDR

Intervention Type RADIATION

Focal LDR to dominant lesion with whole gland 19 Gy HDR

Interventions

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LDR/HDR

Focal LDR to dominant lesion with whole gland 19 Gy HDR

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sunnybrook Odette Cancer Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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DELIGHT

Identifier Type: -

Identifier Source: org_study_id

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