PET/CT Characterization of Treatment Resistance

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT05647564
Status
Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • F-fluorodeoxyglucose positron emission tomography (FDG PET) — DIAGNOSTIC_TEST
    Imaging scan
  • prostate-specific membrane antigen positron emission tomography (PSMA PET) — DIAGNOSTIC_TEST
    Imaging scan

Study Details

This study will use different types of medical imaging to assess how lesions from advanced prostate cancer become resistant to second-generation AR-targeted therapy, and how the different types of imaging compare in that assessment. Participants in this study have advanced prostate cancer and are either scheduled to start a second-generation androgen receptor (AR) targeted therapy (such as enzalutamide, abiraterone, or apalutamide) or are already being treated with one. Participants can expect to be in the study for at least 9 months, and up to 2 years.

Key Dates

First listed
Dec 12, 2022
Start date
Mar 6, 2023
Status verified
Feb 2026
Primary completion
Sep 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Other: Intrinsic Resistance Cohort (Cohort A)
    Participants assigned to Cohort A have advanced prostate cancer and are scheduled to start a second-generation AR-targeted (such as enzalutamide, abiraterone, darolutamide, or apalutamide) or PSMA directed (e.g. Lu177-PSMA) therapies .
  • Other: Acquired Resistance Cohort (Cohort B)
    Participants are assigned to Cohort B if they have advanced prostate cancer, are already on a second-generation AR-targeted therapy, and have shown an increase in their PSA (prostate-specific antigen) levels.

Primary Outcome Measure

Characterize intrinsic resistance based on FDG and PSMA PET through change in individual lesion update levels. [ Time Frame: Baseline to 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WisconsinMadisonWisconsin53705
Cancer Connect
800-622-8922
Christos Kyriakopoulos, MD (PRINCIPAL_INVESTIGATOR)

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