Recruiting
Phase 2

PSMA

Sponsor:

University of Washington

Code:

NCT04175431

Conditions

Prostate Adenocarcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Positron Emission Tomography

Lymphadenectomy

Radiation Therapy

Abiraterone Acetate

Prednisone

Study Details

Brief summary:

This phase II trial studies how well prostate specific membrane antigen (PSMA) or fluciclovine positron emission tomography (PET)/computed tomography (CT) site-directed therapy works for treating patients with prostate cancer. PSMA or fluciclovine PET/CT may detect prostate cancer early and may help to show whether patients benefit from site directed treatment to PET detected abnormalities.

Conditions

Prostate Adenocarcinoma

Study ID

NCT04175431

Start date

Sep 30, 2020

Status verified date

Jul, 2026

Completion date

Jul 1, 2037

Anticipated

Primary completion date

Jul 1, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Group I (fluciclovine PET/CT)

Patients for whom initial fluciclovine or PSMA PET/CT does not reveal any abnormalities outside the prostatic fossa undergo PSA rechecks every 3 months, and undergo fluciclovine or PSMA PET/CT once PSA is > 2 ng/ml. If still no abnormalities are found outside of the prostatic fossa, patients continue to undergo PSA rechecks every 3 months, and undergo fluciclovine or PSMA PET/CT once PSA is > 5 ng/ml. Patients are off study for treatment plan once PSA reaches 10 ng/ml.

experimental: Group II (surgery, radiotherapy, abiraterone, prednisone)

Patients undergo fluciclovine or PSMA PET/CT and who have =< 3 regions of metastatic disease outside of the prostatic fossa that are amenable to metastasis-directed therapy undergo lymphadenectomy or radiation therapy. Six to ten weeks after surgery, patients receive abiraterone acetate 1000 mg PO QD and prednisone PO QD. Treatment repeats every 4 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may start radiation therapy after 2 cycles of abiraterone acetate and prednisone.

experimental: Group III (abiraterone, prednisone)

Patients undergo fluciclovine or PSMA PET/CT and who have > 3 regions of metastatic disease receive abiraterone acetate and prednisone as in Group II.

Interventions

Positron Emission Tomography

Undergo fluciclovine PET/CT

Lymphadenectomy

Undergo lymphadenectomy

Radiation Therapy

Undergo radiation therapy

Abiraterone Acetate

Given PO

Prednisone

Given PO

Computed Tomography

Undergo fluciclovine PET/CT

Abiraterone

Given PO

PSMA PET Scan

Undergo PSMA PET scan

Primary outcome measure

  • Undetectable PSA (< 0.2 ng/mL) rate [ Time Frame: At 2 years ]

Central Contacts and Locations

Central contacts

Jane Romani

206-606-1909jromani@fredhutch.org

Locations

University of Pittsburgh Cancer Institute (UPCI)

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Principal Investigator:

Risa Wong

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Jane Romani

206-606-1909jromani@fredhutch.org

Principal Investigator:

Evan Yu

More Information

Sponsor

University of Washington

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2026-07-07.