Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT05647564

PET/CT Characterization of Treatment Resistance

Led by University of Wisconsin, Madison · Updated on 2026-02-17

25

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

PET/CT Characterization of Treatment Resistance

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically proven adenocarcinoma of the prostate.
  • At least 1 radiographic metastasis seen on conventional CT imaging or bone scan.
  • Progressive prostate cancer with at least two separate increases in PSA over nadir and an absolute PSA value of at least 2 ng/ml for intrinsic resistance cohort.
  • Candidate for second-generation androgen receptor inhibitor or Lu177-PSMA radioligand therapy for intrinsic resistance cohort.
  • Male aged over 18 years.
  • Ability and willingness to lie flat for at least 30 minutes during imaging.
  • Informed consent signed after understanding study risks.
  • Life expectancy of at least 12 months.
  • For acquired resistance cohort, currently receiving second-generation AR inhibitor with prior PSA decline followed by PSA increase within 12 weeks of first documented increase.
Not Eligible

You will not qualify if you...

  • Uncontrolled diabetes (fasting blood sugar over 200 mg/dL or inability to safely hold diabetes medication or fast 6 hours before FDG PET scan).
  • Prior treatment with second-generation AR inhibitor in metastatic setting for intrinsic resistance cohort.
  • Pain or symptoms from metastatic prostate cancer requiring opioid analgesics.
  • Known neuro-endocrine prostate cancer.
  • Prior radioisotope therapy for castration-resistant prostate cancer.
  • Vulnerable populations such as incarcerated subjects, those unable to provide informed consent, and non-English speaking patients.

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Wisconsin

Madison, Wisconsin, United States, 53705

Actively Recruiting

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Research Team

C

Cancer Connect

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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PET/CT Characterization of Treatment Resistance | DecenTrialz