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

NCT06200974 | Recruiting

• 1 other identifier: H23-02872
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Changes in biomolecular composition in prostate cancer after high dose rate prostate brachytherapy as measured by Raman spectroscopy

  We will report the most important biomolecules altered by radiation (importance determined by the relative change of the score as a component of the Raman spectrum before and after radiation) and whether that observed change corelates with PSA outcome for each individual patient

  1-2 weeks, PSA: 0-10 years

• ctDNA detection following HDR Brachytherapy

  Number of patients with a (transient) increase in circulating tumor DNA after a single fraction of high-dose rate prostate brachytherapy will be reported

  0-4 weeks

• Immunogenicity against somatic mutations

  single cell-RNA sequencing of immune cell populations before and after 13.5 Gray of radiation will be used for each individual patient and the number of patients with a change in gene expression (through activation or inactivation) will be reported

  0-4 weeks

• Gut microbiome

  To determine microbial composition before brachytherapy and report for the individual patient whether diversity in composition is changed or skewed after treatment with high dose rate prostate brachytherapy. Second assessment is after completion of both fractions of radiation. Number of patients with alteration in microbial composition will be reported.

  0-4 weeks

Secondary Outcomes (3)

• Response Outcome: PSA Nadir

  0-10 years

• Response Outcome: 4-year PSA

  0-4 years

• Acute and long term toxicity

  0-10 years

Study Arms (1)

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.

Radiation: High dose rate prostate brachytherapy

Interventions

High dose rate prostate brachytherapy RADIATION

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.

Also known as: HDR brachytherapy

High dose rate prostate brachytherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with localized prostate cancer suitable for brachytherapy as monotherapy.

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

Sponsors & Collaborators

• Vancouver Prostate Centre: collaborator
• British Columbia Cancer Agency: lead
• BC Cancer Foundation: collaborator
• University of British Columbia: collaborator

Study Sites (1)

British Columbia Cancer Center for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood and tissue

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Juanita M Crook, MD

  Radiation Oncologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juanita M Crook, MD

CONTACT

250 712 3958; jcrook@bccancer.bc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiation Oncology

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 11, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): February 1, 2038
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)