Recruiting

HDR Brachytherapy

Sponsor:

British Columbia Cancer Agency

Code:

NCT06200974

Conditions

Localized Prostate Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High dose rate prostate brachytherapy

Study Details

Brief summary:

This is an observational single-center trial for patients with localized prostate cancer suitable for High Dose Rate (HDR) brachytherapy as monotherapy. This study takes a multi-omics approach to study the mechanism of action of HDR brachytherapy through metabolomics, immunological, transcriptomics, and spectroscopic profiling. The results of this study will clarify the optimal dose for HDR prostate brachytherapy by documenting the dose-response relationship seen in the changing tumor metabolites after HDR brachytherapy and investigate the immunogenicity of HDR brachytherapy.

Conditions

Localized Prostate Carcinoma

Study ID

NCT06200974

Start date

Feb 1, 2024

Status verified date

Jan, 2026

Completion date

Feb 1, 2038

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Favorable risk and intermediate-risk prostate cancer with estimated life expectancy of at least 10 years.
  • Clinical stage T1c-T2b, PSA < 20, Gleason < 8
  • ECOG 0-1
  • Low tier intermediate-risk prostate cancer is defined by: a single NCCN intermediate risk factor (either Gleason 7(3+4) and PSA < 10 ng/ml OR Gleason 6 and PSA 10-20 ng/ml)
  • Extensive favorable-risk disease is defined as: clinical stage T1c-T2a, PSA < 10, Gleason 6, ≥ 50% of biopsy cores containing cancer, PSA density > 0.2 ng/cc,
  • Selected intermediate risk patients not defined above

  • T1c/T2a
  • PSA < 10 and Gleason 4+3
  • PSA > 10 (< 20) and Gleason 3+4
  • PSA 10-15 ng/ml and Gleason 4+3 and < 33% cores involved
  • Max tumor length in any core 10 mm
  • No androgen deprivation therapy (ADT)
  • Signed study specific informed consent.

Exclusion Criteria:

  • Prior radical surgery for carcinoma of the prostate,
  • Prior pelvic radiation
  • Prior chemotherapy for prostate cancer,
  • Claustrophobic or unable to undergo MRI
  • Patients unsuitable for general anesthesia, on blood thinners which cannot be stopped for 24 hours, or who have contraindications to radiotherapy such as systemic sclerosis, or inflammatory bowel disease

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

High dose rate prostate brachytherapy

Radiation. High dose rate prostate brachytherapy is delivered under anesthesia in 2 procedures, 1-2 weeks apart.

HDR brachytherapy is also accomplished as an out-patient.

Interventions

High dose rate prostate brachytherapy

Temporary implantation of radioactive material into the prostate in the form of a stepping source of Iridium 192 that travels through 16-18 needles or catheters strategically placed through the prostate.

Primary outcome measure

  • Changes in biomolecular composition in prostate cancer after high dose rate prostate brachytherapy as measured by Raman spectroscopy [ Time Frame: 1-2 weeks, PSA: 0-10 years ]
  • ctDNA detection following HDR Brachytherapy [ Time Frame: 0-4 weeks ]
  • Immunogenicity against somatic mutations [ Time Frame: 0-4 weeks ]
  • Gut microbiome [ Time Frame: 0-4 weeks ]

Central Contacts and Locations

Central contacts

Juanita M Crook, MD

250 712 3958jcrook@bccancer.bc.ca

Locations

British Columbia Cancer Center for the Southern Interior

Recruiting

Kelowna, British Columbia, Canada, V1Y 5L3

Contacts

Juanita Crook, MD

250 712 3958jcrook@bccancer.bc.ca

More Information

Sponsor

British Columbia Cancer Agency

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Keywords

  • Brachytherapy
  • TRACKS
  • High Dose Rate
  • Prostate cancer
  • favorable risk
  • intermediate risk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by British Columbia Cancer Agency on 2026-02-02.