Multi-omic Approach to Study High Dose Rate (HDR) Brachytherapy for Favorable Risk and Low Tier Intermediate Risk Prostate Cancer

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 10-15 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.

Locations
Other Locations
Canada
British Columbia Cancer Center for the Southern Interior
RECRUITING
Kelowna
Contact Information
Primary
Juanita M Crook, MD
jcrook@bccancer.bc.ca
250 712 3958
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2038-02-01
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: British Columbia Cancer Agency
Collaborators: BC Cancer Foundation, Vancouver Prostate Centre, University of British Columbia

This content was sourced from clinicaltrials.gov