NCT02918253

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
19mo left

Started Oct 2016

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Oct 2016Dec 2027

First Submitted

Initial submission to the registry

September 27, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

October 14, 2016

Completed
11.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

11.1 years

First QC Date

September 27, 2016

Last Update Submit

March 3, 2025

Conditions

Prostate Cancer

Keywords

High dose-rate brachytherapy

Outcome Measures

Primary Outcomes (1)

  • number of patients achieving biochemical control

    2 yrs

Study Arms (2)

Tumour visible on MRI

EXPERIMENTAL

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

Radiation: targeted focal HDR brachytherapy

No tumour visible on MRI

ACTIVE COMPARATOR

Whole-gland HDR Brachytherapy

Radiation: Whole-gland HDR Brachytherapy

Interventions

targeted focal HDR brachytherapyRADIATION
Tumour visible on MRI
Whole-gland HDR BrachytherapyRADIATION

Control/Standard of Care

No tumour visible on MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Alejandro Berlin, MD

CONTACT

alejandro.berlin@rmp.uhn.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2016

First Posted

September 28, 2016

Study Start

October 14, 2016

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)