Prostate Specific Membrane Antigen (PSMA) or (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Washington
Study ID
NCT04175431
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Prostate Adenocarcinoma

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Positron Emission Tomography — PROCEDURE
    Undergo fluciclovine PET/CT
  • Lymphadenectomy — PROCEDURE
    Undergo lymphadenectomy
  • Radiation Therapy — RADIATION
    Undergo radiation therapy
  • Abiraterone Acetate — DRUG
    Given PO
  • Prednisone — DRUG
    Given PO
  • Computed Tomography — PROCEDURE
    Undergo fluciclovine PET/CT
  • Abiraterone — DRUG
    Given PO
  • PSMA PET Scan — PROCEDURE
    Undergo PSMA PET scan

Study Details

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.

Key Dates

Start date
Sep 30, 2020
Status verified
Dec 2025
Primary completion
Jul 1, 2028
Completion
Jul 1, 2033

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232
Risa Wong (PRINCIPAL_INVESTIGATOR)
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Jane Romani
[email protected]
206-606-1909
Evan Yu (PRINCIPAL_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By research site
University of Pittsburgh Cancer Institute (UPCI)· Pittsburgh, PAFred Hutch/University of Washington Cancer Consortium· Seattle, WA

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