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Hemi-Ablative Prostate Brachytherapy

NCT02632669 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2022-11-01

No results posted yet for this study

Summary

This clinical study will evaluate side effects, quality of life and cancer control in patients with prostate cancer diagnosed on only one side of the prostate gland.

The diagnosis of unilateral prostate cancer will be made by means of a prostate transperineal template biopsy (TTB) and multiparametric magnetic resonance imaging (mpMRI).

Patients will be treated with low dose rate brachytherapy, using permanent iodine seed implants.Treatment will be limited to the side of the gland where the cancer has been diagnosed and is therefore called "focal" brachytherapy.

Prostate brachytherapy is usually applied to the whole prostate gland. After whole gland prostate brachytherapy urinary, bowel and sexual function may be affected. In this focal approach, the side effects will be evaluated by means of patient questionnaires.These will be repeated at various intervals after treatment.The results will be compared to the same questionnaires responded by patients who have undergone whole gland brachytherapy.Therefore an assessment can be made whether focal therapy produces fewer side effects than whole gland brachytherapy.The observation period will last for two years after treatment. A biopsy and mpMRI will be repeated after two years to evaluate prostate cancer control.

Conditions

  • Prostatic Neoplasms
  • Cancer of the Prostate

Interventions

RADIATION

Hemigland focal LDR brachytherapy

The treatment is limited to the hemigland that has been diagnosed with unilateral low to intermediate risk prostate cancer by means of pre-treatment staging with mpMRI and transperineal template biopsy. The affected hemigland will be treated with iodine-125 to a prescription dose of 145Gy. Patients will be assessed at baseline and subsequently at 6 weeks, 3, 6, 9, 12,18, 24 months after treatment with PSA and EN2 measurements and validated questionnaires relating to erectile, urinary, and bowel function and general health related quality of life. mpMRI and transperineal template biopsy will be performed 24 months after treatment.

Sponsors & Collaborators

  • Royal Surrey County Hospital NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Stephen Langley, MD · Royal Surrey NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-06
Primary Completion
2018-06-20
Completion
2018-08-31

Countries

  • United Kingdom

Study Locations

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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 NCT02632669 on ClinicalTrials.gov