Hemiablative Focal Brachytherapy Pilot Study

  • STATUS
    Recruiting
  • End date
    Jul 21, 2025
  • participants needed
    20
  • sponsor
    St George Hospital, Australia
Updated on 21 January 2021
biopsy of prostate
brachytherapy
multiparametric magnetic resonance imaging
adenocarcinoma
adenocarcinoma of prostate

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.

Details
Condition Malignant neoplasm of prostate, Prostate Cancer, Prostate Cancer, Early, Recurrent, Prostatic disorder, Prostate Disorders, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, prostate carcinoma, prostate cancers
Treatment Transperineal template guided mapping biopsy, multiparametric MRI, Hemiablative Focal Brachytherapy
Clinical Study IdentifierNCT02643511
SponsorSt George Hospital, Australia
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

\. Patients must have histologically proven adenocarcinoma of the prostate. 2. Patients must have low or low-tier intermediate prostate cancer
Low risk prostate cancer patients must have
Clinical stage T2a
Gleason score =6 and iPSA 10 ng/ml
< 25% cores positive, < 50 % cancer in each core involved
Low tier Intermediate risk patients may have
Clinical stageT2a
Gleason score 3+4=7
PSA 10 ng/ml
< 25% cores positive, < 50 % cancer in each core 3. Patients must be fit for general anesthetic. 4. Patients must have unilateral disease on biopsy 5. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2. 6. Men 65 years of age with a life expectancy estimated to be >10 years. 7\. Patients must have no contraindications to interstitial prostate brachytherapy. 8. Patients on anticoagulant therapy must be able to stop therapy safely for at least 7 days. 9. Patients must not have any contraindications to MRI 10. IPSS <=16

Exclusion Criteria

Does not meet staging criteria for low risk or low tier intermediate risk prostate cancer
Bilateral prostatic disease
Prior hormonal therapy
Prior Transurethral resection or middle lobe resection
Recent IPSS>
Unfit for general anesthetic
MRI contraindicated
Unable to cease anticoagulant therapy
Life expectancy < 10 years
IPSS>16
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