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PET/CT Characterization of Treatment Resistance

PET/CT Characterization of Treatment Resistance of AR-targeted Therapies in mCRPC

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years
  • Procedures mentioned: CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants can expect to be in the study for at least 9 months, and up to 2 years."
  • "These scans are done simultaneously with computed tomography (CT) scanning."
  • "Participants will be scheduled to have 6 scans, 3 FDG PET/CT scans and 3 PSMA PET/CT scans."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares imaging scans to learn how advanced prostate cancer stops responding to newer treatments that block male hormone signals. It is for men with prostate cancer that has spread who are starting or taking these treatments; one group may receive Lu177-PSMA, a targeted radiation treatment. Participation lasts at least 9 months and up to 2 years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be a man older than 18 with prostate adenocarcinoma, a type of cancer confirmed by a tissue test.
  • Have at least one area of cancer spread seen on a CT scan or bone scan.
  • For the group studying resistance from the start: be eligible for a newer treatment that blocks male hormone signals or for Lu177-PSMA targeted radiation treatment.
  • For men getting hormone-signal treatment in the resistance-from-the-start group: PSA, a blood marker for prostate cancer, must rise at least twice above its lowest level and be at least 2 ng/mL.
  • For the group studying resistance that develops later: be taking a newer hormone-signal treatment. PSA must have fallen and then risen while still on treatment. Join within 12 weeks of the first recorded rise.
  • Be able to follow all study steps, including being willing and able to lie flat for at least 30 minutes for scans.
  • Understand that the study is exploratory, understand its possible risks, and sign the approved consent form.
  • Be expected to live at least 12 months.

Who can't join

  • Have uncontrolled diabetes: fasting blood sugar above 200 mg/dL, or be unable to safely pause diabetes medicine or fast for 6 hours before the FDG PET scan.
  • For the hormone-treatment group studying resistance from the start: have already taken a newer hormone-signal blocker for cancer that had spread. Earlier use before or after the main treatment is allowed unless the cancer worsened while taking it.
  • Have pain or other symptoms from cancer spread that require opioid pain medicines.
  • Have known neuroendocrine prostate cancer, a specific type of prostate cancer.
  • Have had radioactive drug treatment for prostate cancer that no longer responds to testosterone-lowering treatment.
  • Be in prison, be unable to give your own informed consent, or not speak English.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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) Exclusion Criteria: * 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) * 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) * Pain or clinical symptoms from metastatic prostate cancer requiring opioid analgesics * Known neuro-endocrine prostate cancer * Prior radioisotope therapy for castration-resistant prostate cancer * 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

Study sites (1)

WI