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

ConditionProstate Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Washington

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo fluciclovine PET/CT

  • Lymphadenectomy

    Procedure/Surgery

    Undergo lymphadenectomy

  • Radiation Therapy

    Radiation

    Undergo radiation therapy

  • Abiraterone Acetate

    Drug

    Given PO

  • Prednisone

    Drug

    Given PO

  • Computed Tomography

    Procedure/Surgery

    Undergo fluciclovine PET/CT

  • Abiraterone

    Drug

    Given PO

  • PSMA PET Scan

    Procedure/Surgery

    Undergo PSMA PET scan

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Group I (fluciclovine PET/CT)Active comparator 3 interventions
Group B: Group II (surgery, radiotherapy, abiraterone, prednisone)Experimental treatment 8 interventions
Group C: Group III (abiraterone, prednisone)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Undetectable PSA (< 0.2 ng/mL) rate

Time frame
At 2 years

Secondary outcomes

1

Total testosterone

Time frame
Up to 7 years
2

Median time to reinitiation of antiandrogen therapy (ADT)

Time frame
Up to 7 years
3

Overall survival

Time frame
Up to 7 years
4

Number of patients with abnormalities within the prostatic fossa with PSA < 10 ng/mL

Time frame
Up to 7 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

Blue Earth Diagnostics

Collaborator

Source ClinicalTrials.gov
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