Site-directed therapy using PSMA or FACBC PET/CT for prostate cancer treatment

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 phase II trial investigates the effectiveness of prostate specific membrane antigen (PSMA) or fluciclovine PET/CT in guiding site-directed therapy for patients with prostate adenocarcinoma. Patients are divided into three groups based on the presence of metastatic disease detected by PET/CT, with treatment options including lymphadenectomy, radiation therapy, and abiraterone acetate combined with prednisone. The study aims to monitor PSA levels and assess the benefits of targeted treatment based on imaging results. Follow-up assessments will occur over several years to evaluate long-term outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient must have histologically or cytologically documented evidence of prostate adenocarcinoma
* Patient must previously have undergone radical prostatectomy
* Patient must previously have undergone either adjuvant or salvage radiation therapy to the prostatic fossa +/- whole pelvis
* Patient must have a prostate specific antigen (PSA) \>= 0.2 and \< 10 ng/mL. If there is only one PSA value that has risen to \>= 0.2 with this biochemical recurrence, a second PSA value must be confirmed to be within \>= 0.2 and \< 10 ng/mL at least 2 weeks from the first value and within 28 days of enrollment
* PSA doubling time must be calculated utilizing either all PSA measurements \> 0.1 ng/mL from most recent biochemically-recurred (BCR) or the most recent 3 PSA measurements \> 0.1 ng/mL (if the latter, all 3 PSA measurements must be \> 2 weeks apart to be used in the calculation). PSA doubling time must be \> 3 months and \< 18 months. The Memorial Sloan Kettering PSA doubling time calculator should be used
* Patient must have no previous evidence of radiographically detectable metastatic prostate cancer by conventional CT and bone scan imaging
* Patient must have total testosterone level \> 120 ng/dL demonstrated within 42 days of enrollment
* Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Absolute neutrophil count (ANC) \>= 1.0 X 10\^9/L
* Platelet count \>= 100 X 10\^9/L
* Hemoglobin \>= 9 g/dL
* Potassium \>= 3.5
* Serum bilirubin =\< 1.5 X upper limit of normal (ULN) or =\< 3 X ULN for patients with documented Gilbert's syndrome
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 X ULN
* Creatinine clearance (Cr Cl) \>= 30 mL/min as estimated by the Cockcroft-Gault criteria or as determined by 24 hour Cr Cl measurement
* Patient must be \>= 18 years of age on day of signing informed consent
* Patient must be able to understand and authorize informed consent

Exclusion Criteria:

* Chronic active hepatitis B or C
* History of a second, non-prostate malignancy that required systemic therapy in the last 2 years except cancer in situ of bladder and non-melanomatous cancers of the skin
* Patient with a serious underlying medical condition that would otherwise impair the patient's ability to undergo fluciclovine or PSMA PET/CT imaging or receive subsequent treatment
* Any condition that would alter the patient's mental status, prohibiting understanding and/or authorization of informed consent
* Expected lifespan of less than 12 weeks
* Inability to lay still for imaging
* Weight \> 300 lbs. (due to equipment specifications)
* Any other underlying medical condition that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned treatment and/or follow up

Where it's running

• University of Pittsburgh Cancer Institute (UPCI)
  Pittsburgh, Pennsylvania, United States Recruiting
• Fred Hutch/University of Washington Cancer Consortium
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Evan Yu — Fred Hutch/University of Washington Cancer Consortium
• Study coordinator: Jane Romani
• Email: jromani@fredhutch.org
• Phone: 206-606-1909

Similar studies

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

• 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

• Next-generation SABR for prostate cancer across Ireland

  This test uses focused high-dose stereotactic radiotherapy (SABR) with urethra-sparing, a rectal spacer, and nerve preservation for men with low-, intermediate-, or selected high-risk prostate cancer to try to control the tumor while reducing side effects.

  Recruiting at 2 sites Phase 2 Cancer Trials Ireland · Dublin, Leinster and 3 other locations · NCT07552168

• Focal HDR-Brachytherapy for Prostate Cancer

  This trial tests using targeted high-dose-rate brachytherapy to treat prostate cancer patients and see if it provides local control with fewer side effects.

  Recruiting Jonsson Comprehensive Cancer Center · Los Angeles, California · NCT07468903

• Shorter androgen deprivation in combination with radiation for high-risk prostate cancer

  Doctors are testing whether 6 months of hormone therapy with radiation works as well as 18 months, for men with high-risk prostate cancer.

  Recruiting Phase 2 University of California, San Diego · La Jolla, California · NCT07364071

• 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.