Prostate Cancer Clinical Trial

Imaging and Genomic Biomarkers to Predict Response in Prostate Cancer

Summary

The purpose of this study is to evaluate the imaging and gene expression biomarkers in prostate cancer. Participants have high-risk prostate cancer and have indicated they will undergo external beam radiation therapy, brachytherapy, and androgen deprivation therapy (EBRT+BTX+ADT). Participants can expect to be in this study for up to 5 years.

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Full Description

This is a pilot study to prospectively investigate potential predictive imaging and genomic biomarkers for patients with high-risk prostate cancer treated with standard of care EBRT + BTX + ADT. The primary imaging modalities that will be evaluated will be PSMA positron emission tomography (PET) and multi-parametric magnetic resonance imaging (MRI). Pre-treatment PET/MRI scans will also be obtained as part of standard of care prior to study enrollment. Response will be assessed on a mid-treatment PET/MRI scan obtained for research purposes after completion of EBRT but prior to brachytherapy boost. Imaging response will be compared to pathology from image-directed prostate biopsies taken at the time of the brachytherapy boost. The primary genomic marker that will be evaluated is a clinically available gene-expression array, Decipher, that will be obtained as part of standard of care prior to study enrollment.

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Eligibility Criteria

Inclusion Criteria:

Age ≥ 18
Histologically confirmed adenocarcinoma of the prostate
Cancer classified as high-risk or very high-risk by National Comprehensive Cancer Network (NCCN) criteria: Grade group ≥4, PSA >20, or primary tumor stage ≥T3a
ECOG performance status 0-1
Agreed to undergo EBRT, high dose rate (HDR) brachytherapy boost, and 18 months of ADT as part of standard of care therapy prior to study enrollment
Able to undergo a HDR brachytherapy implant: Pre-radiation IPSS score ≤15 with or without medical management; prostate ≤60 cc as measured by MRI or ultrasound; no prior trans-urethral resection of prostate (TURP); and, median lobe extending into the bladder <1 cm
No prior or concurrent malignancy unless disease-free for at least 5 years

Exclusion Criteria:

Evidence of regional or distant metastatic disease on pre-treatment bone scan, pelvic MRI, and/or CT of the abdomen/pelvis
Prior pelvic radiation therapy

Study is for people with:

Prostate Cancer

Phase:

Early Phase 1

Estimated Enrollment:

30

Study ID:

NCT05477823

Recruitment Status:

Recruiting

Sponsor:

University of Wisconsin, Madison

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There is 1 Location for this study

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University of Wisconsin
Madison Wisconsin, 53705, United States More Info
Cancer Connect
Contact
800-622-8922
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Early Phase 1

Estimated Enrollment:

30

Study ID:

NCT05477823

Recruitment Status:

Recruiting

Sponsor:


University of Wisconsin, Madison

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