Multi-omic Approach to Study HDR Brachytherapy for Favorable Risk and Low Tier Intermediate Risk Prostate Cancer

Recruiting now

Conditions studied: Localized Prostate Carcinoma

In brief

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.

Key facts

Study ID

NCT06200974

Run by

British Columbia Cancer Agency

People needed

100

Starts

2024-02-01

Expected to finish

2038-02-01

Last updated by the study team

2026-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• British Columbia Cancer Center for the Southern Interior — Kelowna, British Columbia, Canada (enrolling)

Full record on ClinicalTrials.gov

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