NCT06200974 Multi-omic Approach to Study HDR Brachytherapy for Favorable Risk and Low Tier Intermediate Risk Prostate Cancer
| NCT ID | NCT06200974 |
| Status | Recruiting |
| Phase | — |
| Sponsor | British Columbia Cancer Agency |
| Condition | Localized Prostate Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-02-01 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Juanita M Crook, MD
PRINCIPAL INVESTIGATOR
Radiation Oncologist
Frequently Asked Questions
Who can join the NCT06200974 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Localized Prostate Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06200974 currently recruiting?
Yes, NCT06200974 is actively recruiting participants. Contact the research team at jcrook@bccancer.bc.ca for enrollment information.
Where is the NCT06200974 trial being conducted?
This trial is being conducted at Kelowna, Canada.
Who is sponsoring the NCT06200974 clinical trial?
NCT06200974 is sponsored by British Columbia Cancer Agency. The principal investigator is Juanita M Crook, MD at Radiation Oncologist. The trial plans to enroll 100 participants.