HDR Focal: Feasibility Study

Sponsor
University Health Network, Toronto (Other)
Overall Status
Recruiting
CT.gov ID
NCT02918253
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
85.6
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Brachytherapy as a monotherapy treatment is highly effective for localized prostate cancer, traditionally being delivered to the whole prostate gland. Lately, low dose rate (LDR) brachytherapy has been increasingly replaced by high dose rate (HDR) brachytherapy treatment schemes. While brachytherapy's oncologic outcomes are excellent, it is not without incidence adverse effects including urinary, rectal, and sexual toxicities that affect the patient's quality of life.

This study will incorporate HDR monotherapy treatment option for early stages and favourable risk prostate cancer.

Additionally, we aim to evaluate the role of focal HDR brachytherapy for well-defined disease based on multiparametric MRI (mpMRI). This approach may offer an option of reducing the treatment toxicities while maintaining oncologic outcomes when compared with whole-gland therapy. Advantages in quality of life could be exhibited in the form of reduced urinary discomfort and incontinence, rectal symptoms, and improved erectile and prostatic gland function. This study would be particularly relevant in the current era of earlier localized prostate cancer detection, where newer imaging modalities (e.g. mpMRI) become a routine component of patient care.

Condition or DiseaseIntervention/TreatmentPhase
  • Radiation: targeted focal HDR brachytherapy
  • Radiation: Whole-gland HDR Brachytherapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
HDR Monotherapy for Prostate Cancer: A Feasibility Study of Focal Radiotherapy Yields
Actual Study Start Date :
Oct 14, 2016
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Tumour visible on MRI

Targeted focal HDR Brachytherapy to dominant lesion +/- whole-gland elective dose

Radiation: targeted focal HDR brachytherapy

Active Comparator: No tumour visible on MRI

Whole-gland HDR Brachytherapy

Radiation: Whole-gland HDR Brachytherapy
Control/Standard of Care

Outcome Measures

Primary Outcome Measures

  1. number of patients achieving biochemical control [2 yrs]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age ≥ 18 years

  • ECOG performance status 0 - 2

  • Histological evidence of prostate adenocarcinoma

  • Low- and favorable intermediate-risk prostate cancer

  • Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed

  • No contraindications to MRI:

  • Absent or unifocal intraprostatic disease (<2 separate/distinct lesions), on multiparametric MRI

  • Prostate gland size <80cc

  • Baseline IPSS <18

  • No TRUP within the past 6 months, nor large TURP defect

  • Absence of radiological evidence of regional or distant metastases (optional evaluation, at physician discretion)

  • No previous pelvic and/or prostate EBRT and/or brachytherapy

  • No contraindications to general anesthesia, or spinal/epidural anesthesia

  • Absence of bleeding diathesis and/or anti-coagulative therapy that cannot be temporarily ceased during brachytherapy

  • No contraindications to endorectal coil, surgically absent rectum, severe hemorrhoids or colorectal surgery

  • Negative past medical history of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, or SLE

  • Absence of latex allergy

  • No other medical conditions deemed by the PI to make patient ineligible for prostate HDR brachytherapy

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Princess Margaret Cancer CentreTorontoOntarioCanadaM5G 2M9

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT02918253
Other Study ID Numbers:
  • 16-5490
First Posted:
Sep 28, 2016
Last Update Posted:
Oct 6, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by University Health Network, Toronto
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2021