Description:
This phase II trial studies how well fluciclovine positron emission tomography (PET)/computed
tomography (CT) site-directed therapy works for treating patients with prostate cancer.
Fluciclovine PET/CT may detect prostate cancer early and may help to show whether patients
benefit from site directed treatment to PET detected abnormalities.
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, Androsta-5 | Group II (surgery, radiotherapy, abiraterone, prednisone) |
Prednisone | Deltasone, Prednicort, Prednisone Intensol, Rayos, Sterapred, Dehydrocortisone, Prednilonga, Servisone | Group II (surgery, radiotherapy, abiraterone, prednisone) |
Abiraterone | 154229-19-3, 17-(3-Pyridyl)androsta-5, 16-dien-3beta-ol, CB 7598 | Group II (surgery, radiotherapy, abiraterone, prednisone) |
Purpose
This phase II trial studies how well fluciclovine positron emission tomography (PET)/computed
tomography (CT) site-directed therapy works for treating patients with prostate cancer.
Fluciclovine PET/CT may detect prostate cancer early and may help to show whether patients
benefit from site directed treatment to PET detected abnormalities.
Detailed Description
OUTLINE: Patients are assigned to 1 of 3 groups.
GROUP I: Patients undergo fluciclovine PET/CT and who do not have any abnormalities outside
the prostatic fossa by fluciclovine PET/CT imaging undergo PSA recheckes every 3 months, and
undergo fluciclovine PET/CT once PSA is > 2 ng/ml. If still no abnormalities are found
outside of the prostatic fossa, patients continue to undergo PSA recheckes every 3 months,
and undergo fluciclovine PET/CT once PSA is > 5 ng/ml. Patients are off study for treatment
plan once PSA reaches 10 ng/ml.
GROUP II: Patients undergo fluciclovine 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. 6 weeks after surgery, patients receive
abiraterone acetate 1000 mg orally (PO) once daily (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 abiraterone acetate and
prednisone.
GROUP III: Patients undergo fluciclovine PET/CT and who have > 3 regions of metastatic
disease receive abiraterone acetate and prednisone as in Group II.
After completion of study treatment, patients are followed up at 37, 49, 61, 73, 85, 97, 109,
and 121 weeks, at 36, 42, 48, 54, 60, and 66 months, and then annually thereafter.
Trial Arms
Name | Type | Description | Interventions |
---|
Group I (fluciclovine PET/CT) | Active Comparator | Patients undergo fluciclovine PET/CT and who do not have any abnormalities outside the prostatic fossa by fluciclovine PET/CT imaging undergo PSA recheckes every 3 months, and undergo fluciclovine PET/CT once PSA is > 2 ng/ml. If still no abnormalities are found outside of the prostatic fossa, patients continue to undergo PSA recheckes every 3 months, and undergo fluciclovine PET/CT once PSA is > 5 ng/ml. Patients are off study for treatment plan once PSA reaches 10 ng/ml. | |
Group II (surgery, radiotherapy, abiraterone, prednisone) | Experimental | Patients undergo fluciclovine 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. 6 weeks after surgery, patients receive abiraterone acetate 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 abiraterone acetate and prednisone. | - Abiraterone Acetate
- Prednisone
- Abiraterone
|
Group III (abiraterone, prednisone) | Experimental | Patients undergo fluciclovine PET/CT and who have > 3 regions of metastatic disease receive abiraterone acetate and prednisone as in Group II. | - Abiraterone Acetate
- Prednisone
- Abiraterone
|
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
June 4, 2021