NCT05647564Recruiting
PET/CT Characterization of Treatment Resistance
PET/CT Characterization of Treatment Resistance of AR-targeted Therapies in mCRPC
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 6 Dec 2022
- Start date
- 6 Mar 2023
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- University of Wisconsin, Madison
- Diseases
- Prostate cancer
- NCT number
- NCT05647564
What you commit to
- Study type: Interventional
- Planned participants: 25
- From 6 Mar 2023 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with second-generation AR inhibitor for prostate cancer in the metastatic disease setting (prior second-generation AR inhibitor in the neoadjuvant or adjuvant setting is permitted unless patient developed progression while on treatment) (INTRINSIC RESISTANCE COHORT, AR-INHIBITOR GROUP ONLY)
- Prior radioisotope therapy for castration-resistant prostate cancer
Other illness
- Pain or clinical symptoms from metastatic prostate cancer requiring opioid analgesics
- Known neuro-endocrine prostate cancer
Lab values
- Must not have uncontrolled diabetes (fasting blood sugar \> 200 mg/dL or inability to safely hold diabetes medication or fast 6 hours prior to FDG PET scan)
Other
- To avoid the possibility of unintended coercion, vulnerable populations such as incarcerated subjects, subjects unable to provide their own informed consent and non-English speaking patients will not be considered
Who the study is looking for
- Histologically proven adenocarcinoma of the prostate.
- At least 1 radiographic metastases as seen on conventional CT imaging or bone scan
- Progressive prostate cancer as evident by at least two separate increase in PSA over nadir, and absolute PSA value at least 2 ng/ml (INTRINSIC RESISTANCE COHORT, ARSI patients ONLY)
- Patients must be candidate for a second-generation androgen receptor (AR) inhibitor (e.g. enzalutamide, abiraterone, darolutamide, apalutamide), or Lu177-PSMA radioligand therapy (INTRINSIC RESISTANCE COHORT ONLY)
- Men of age \>18 years.
- Patients must be able to comply with all study procedures, including having both the ability and willingness to lie flat for ≥ 30 minutes during imaging
- Patients must be informed of the exploratory nature of the study and its potential risks, and must sign IRB-approved consent form indicating such understanding.
- Life-expectancy at least 12 months
- Patients currently receiving a second-generation androgen receptor (AR) inhibitor (e.g. enzalutamide, abiraterone, darolutamide, apalutamide) and must have had 1) PSA decline on treatment and 2) now have PSA increase over nadir while still on treatment (patients must be registered within 12 weeks of first documented PSA increase) (ACQUIRED RESISTANCE COHORT ONLY)
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Wisconsin Coordinator of this site? Confirm its status | Madison | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.