Using blood tests to predict treatment response in advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will track men with metastatic castration-resistant prostate cancer as they undergo standard treatment to identify biomarkers in circulating tumor cells (CTCs) that may indicate their response to therapy. By analyzing blood samples and archival tumor biopsy samples, researchers aim to compare the genetic and protein profiles of patients who respond well to treatment against those who do not. The goal is to enhance the understanding of how certain biomarkers can predict treatment outcomes, potentially leading to more personalized cancer care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients will be eligible for inclusion in this study only if all of the following criteria apply:

1. Histologically confirmed diagnosis of adenocarcinoma of the prostate. Patients with pure small cell/neuroendocrine tumors of the prostate are not permitted.
2. Radiographic evidence of metastatic disease by CT, MRI, or PET imaging.
3. Prior documented disease progression on one potent AR inhibitor (darolutamide, abiraterone, enzalutamide, or apalutamide or combinations of these) in any disease setting (mHSPC, nmCRPC, mCRPC) based on sequential PSA rises or radiographic progression.
4. Planned therapy with either standard of care enzalutamide and/or abiraterone acetate or another potent AR inhibitor (darolutamide, apalutamide if available) within the coming 6 weeks
5. Castrate levels of testosterone (\<50 ng/dl) at most recent assessment and/or documented ongoing Androgen Deprivation Therapy.
6. Evidence of disease progression based on a rising PSA on or following most recent therapy as evidenced by the following:

   1. Consecutive PSA rises at least 2 weeks apart
   2. Minimum PSA of 1.0 ng/dl prior to entry
7. Age \> 18 years.
8. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

A patient will not be eligible for inclusion in this study if any of the following criteria apply:

1. History of intercurrent or past medical or psychiatric illness including active stage IV malignancy that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).
2. Unwillingness to be followed longitudinally for serial CTC biomarker studies.
3. Life expectancy \< 6 months
4. Planned combination therapy with radiation or other systemic therapies other than ADT and bone health agents.

Where it's running

• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• Duke University Medical Center
  Durham, North Carolina, United States Recruiting
• University of Wisconsin-Madison
  Madison, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Andrew Armstrong, MD — Duke University
• Study coordinator: Kellie Shobe, MS, BSN, RN
• Email: kellie.shobe@duke.edu
• Phone: 919-684-8299

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• MRT-2359 plus apalutamide in advanced prostate cancer

  This Phase 2 trial tests whether taking MRT-2359 with apalutamide can lower PSA in men with castration-resistant prostate cancer.

  Recruiting at 7 sites Phase 2 Monte Rosa Therapeutics, Inc · Los Angeles, California and 13 other locations · NCT07745361

• PSMA-targeted therapy with hormone suppression for low-volume metastatic prostate cancer

  This phase II trial tests leuprolide acetate alone versus with 177Lu-PSMA-617 (with or without abiraterone acetate and prednisone) in men with hormone-sensitive, low-volume metastatic prostate cancer.

  Recruiting Phase 2 Mayo Clinic · Rochester, Minnesota · NCT07650240

• Lower-dose radiation to parts of the prostate for some men with prostate cancer

  This study tests whether a smaller amount of radiation aimed at specific parts of the prostate can reduce side effects compared with giving the full prostate the same dose.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07635238

• JANX014 for metastatic castration-resistant prostate cancer

  This trial will test whether JANX014 is safe, how your body handles it, and whether it shows signs of benefit in adults with metastatic castration-resistant prostate cancer who have already had anti-androgen therapy and typically a taxane.

  Recruiting at 6 sites Phase 1 Janux Therapeutics · La Jolla, California and 5 other locations · NCT07545811

• Epidemiology, diagnosis, and treatment patterns of prostate cancer in Algeria

  This project collects medical and treatment information to see how prostate cancer is diagnosed and managed in Algerian men with confirmed disease.

  Recruiting at 21 sites Société Algérienne de Formation et Recherche en Oncologie · Adrar, Algeria and 23 other locations · NCT07484971

• PSMA PET/CT plus MRI to find higher‑grade prostate cancer in men on active surveillance

  This study tries adding rhPSMA-7.3 (flotufolastat F18) PET/CT to standard mpMRI to see if it finds higher-grade prostate cancer in men on active surveillance.

  Recruiting Phase 2 Icahn School of Medicine at Mount Sinai · New York, New York · NCT07285057

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.