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Hemiablative Focal Brachytherapy Pilot Study

NCT02643511 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-12-31

No results posted yet for this study

Summary

Whole gland LDR brachytherapy has been a well established modality of treating low risk prostate cancer. Treatment in a focal manner has the advantages of reduced toxicity to surrounding organs.

AIM: To determine the utility of focal LDR brachytherapy in form of hemiablative treatment for localized prostate cancer demonstrating the feasibility of the delivery of the prescription dose to the half of the prostate in terms of meeting standard dosimetric parameters while respecting same or lower tolerance doses of adjacent normal organs.

To determine acute and late rectal, urinary and sexual toxicity after this procedure.

To assess the change from baseline in QOL indicators at specific time intervals using validated international questionnaires \[International Prostate Symptom Score ( IPSS), International Index of Erectile Function ( IIEF ), Expanded Prostate Cancer Index (EPIC)\] after this treatment.

To evaluate the local tumour control in terms of biopsy outcomes after focal brachytherapy 36 months after the treatment.

To compare target coverage and relative doses to the rectum and the urethra for the same patient performing a hemigland treatment planning vs Whole gland treatment planning.

STUDY DESIGN: Multi-institution prospective trial to determine whether hemiablative treatment with LDR for prostate cancer is dosimetrically safe and feasible.This study will record data for 20 patients with ipsilateral with low and low tier intermediate risk disease.The study will record quality of life parameters in particular in terms of urinary, rectal and sexual function side effects.

INTERVENTION:

* Baseline Transperineal Template guided mapping prostate biopsy with \>20 cores (not required if already performed)
* Multiparametric MRI within the 3 months prior to registration and at 18 \& 36 months.
* Hemigland prostate region will be targeted with the prescription dose and receive 144 Gy of Iodine125 (I125).
* The quality of life assessment will focus on erectile function, urinary function, bowel function, and general health related quality of life
* Postimplant CT Planning day 30 after the implant for quality assurance.

MEASUREMENT OF ENDPOINTS :

Dosimetric parameters record, Toxicity and QOL evaluation forms, PSA follow up and biopsies at 36 months to assess local control.

Conditions

Interventions

RADIATION

Transperineal template guided mapping biopsy, multiparametric MRI, Hemiablative Focal Brachytherapy

A re-staging transperineal template guided mapping prostate biopsy as currently performed at participating institutions. Hemiablative Focal brachytherapy will be performed . The affected half of the prostate will be targeted with the prescription dose and receive 145 Gy of Iodine-125 (I-125). A postimplant dosimetry will be performed 30 days after procedure. The quality-of-life assessment will focus on erectile function, urinary function, bowel function, and general health related quality of life. The patients will complete this assessment at baseline and then 4 weeks, 6 months, 12 months, 20 months, 24 months, 32 months and 36 months after treatment. A second transperineal biopsy will be performed 36 months after the implant.

Sponsors & Collaborators

  • St George Hospital, Australia

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-07-31
Completion
2025-07-31

Countries

  • Australia

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02643511 on ClinicalTrials.gov