Description:
This phase II trial studies how well fluciclovine positron emission tomography (PET)/computed
tomography (CT) improves long-term outcomes by facilitating early identification of
metastatic prostate cancer amenable to both systemic and site-directed definitive therapy.
Title
- Brief Title: Fluciclovine (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study
- Official Title: Fluciclovine (FACBC) PET/CT Site-Directed Therapy of Oligometastatic Prostate Cancer (Flu-BLAST-PC)
Clinical Trial IDs
- ORG STUDY ID:
RG1004972
- SECONDARY ID:
NCI-2019-07437
- SECONDARY ID:
P30CA015704
- SECONDARY ID:
10349
- NCT ID:
NCT04175431
Conditions
- Prostate Adenocarcinoma
- PSA Level Greater Than or Equal to 0.5
- PSA Level Less Than Ten
Interventions
Drug | Synonyms | Arms |
---|
Abiraterone Acetate | 154229-18-2, Yonsa, Zytiga | Group II (ADT/abiraterone/prednisone +/- surgery +/- RT) |
Prednisone | Deltasone, Prednicort, Prednisone Intensol, Rayos, Sterapred | Group II (ADT/abiraterone/prednisone +/- surgery +/- RT) |
Purpose
This phase II trial studies how well fluciclovine positron emission tomography (PET)/computed
tomography (CT) improves long-term outcomes by facilitating early identification of
metastatic prostate cancer amenable to both systemic and site-directed definitive therapy.
Detailed Description
OUTLINE: Patients are assigned to 1 of 3 groups.
GROUP I (observation with fluciclovine PET/CT): Patients who do not have any abnormalities
outside the prostatic fossa by fluciclovine PET/CT imaging undergo prostate-specific antigen
(PSA) rechecks every 3 months once PSA is > 2 ng/ml. If still no abnormalities are found,
patients continue to undergo PSA rechecks every 3 months once PSA is > 5 ng/ml. Patients are
off study once PSA reaches 10 ng/ml.
GROUP II (ADT/abiraterone/prednisone +/- surgery +/- RT): Patients who have =< 3 regions of
metastatic disease outside the prostatic fossa may undergo lymphadenectomy and/or radiation
therapy, depending on the location of metastases. Patients with surgically treatable disease
receive androgen deprivation therapy (ADT) comprising any luteinizing hormone-releasing
hormone (LHRH) agent, abiraterone acetate 1000 mg orally (PO) once daily (QD), and prednisone
PO QD 6 weeks after surgery. Patients with radiation treatable disease receive 2 cycles of
ADT, abiraterone acetate, and prednisone followed by radiation therapy. Treatment repeats
every 4 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.
GROUP III (ADT/abiraterone/prednisone): Patients who have > 3 regions of metastatic disease
receive ADT, abiraterone acetate, and prednisone as in Group II.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, then annually thereafter.
Trial Arms
Name | Type | Description | Interventions |
---|
Group I (observation with fluciclovine PET/CT) | Active Comparator | Patients who do not have any abnormalities outside the prostatic fossa by fluciclovine PET/CT imaging undergo PSA rechecks every 3 months once PSA is > 2 ng/ml. If still no abnormalities are found, patients continue to undergo PSA rechecks every 3 months once PSA is > 5 ng/ml. Patients are off study once PSA reaches 10 ng/ml. | |
Group II (ADT/abiraterone/prednisone +/- surgery +/- RT) | Experimental | Patients who have =< 3 regions of metastatic disease outside the prostatic fossa may undergo lymphadenectomy and/or radiation therapy, depending on the location of metastases. Patients with surgically treatable disease receive ADT comprising any LHRH agent, abiraterone acetate 1000 mg PO QD, and prednisone PO QD 6 weeks after surgery. Patients with radiation treatable disease receive 2 cycles of ADT, abiraterone acetate, and prednisone followed by radiation therapy. Treatment repeats every 4 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. | - Abiraterone Acetate
- Prednisone
|
Group III (ADT/abiraterone/prednisone) | Experimental | Patients who have > 3 regions of metastatic disease receive ADT, abiraterone acetate, and prednisone as in Group II. | - Abiraterone Acetate
- Prednisone
|
Eligibility Criteria
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
- PSA doubling time must be calculated utilizing all PSA measurements from most recent
biochemically-recurred (BCR). 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 28 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 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 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Undetectable PSA (< 0.2 ng/mL) rate |
Time Frame: | At 2 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Total testosterone |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Measure: | Median time to reinitiation of antiandrogen therapy (ADT) |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Measure: | Overall survival |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Measure: | Number of patients with abnormalities within the prostatic fossa with PSA < 10 ng/mL |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Measure: | Number of patients without abnormalities with PSA < 10 ng/mL |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Measure: | Number of patients with PSA < 10 mg/mL and > 3 regions of metastatic prostate cancer on fluciclovine PET/CT |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | University of Washington |
Last Updated
November 25, 2020