Prostate AdenocarcinomaPhase 2NCT04175431
Prostate Specific Membrane Antigen (PSMA) or (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study
A Phase 2 study testing Positron Emission Tomography, Lymphadenectomy and Radiation Therapy in people with Prostate Adenocarcinoma, run by University of Washington at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Positron Emission Tomography, Lymphadenectomy and Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2020to 1 Jul 2037
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
Risa Wong
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Jane Romani, 206-606-1909, jromani@fredhutch.org
Evan Yu
About this study
Official title: Prostate Specific Membrane Antigen (PSMA) or Fluciclovine (FACBC) PET/CT Site-Directed Therapy of OLigometASTatic Prostate Cancer (P-Flu-BLAST-PC): A Multicenter Study
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.
Read the detailed description
OUTLINE: Patients are assigned to 1 of 3 groups.
GROUP I: 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.
GROUP II: 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 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 of abiraterone acetate and prednisone.
GROUP III: Patients undergo fluciclovine or PSMA 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.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Positron Emission Tomography, Lymphadenectomy, Radiation Therapy, Abiraterone Acetate, Prednisone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, PET Scan, positron emission tomography scan, proton magnetic resonance spectroscopic imaging
Undergo fluciclovine PET/CT
LymphadenectomyProcedure or surgery
Also called Lymph Node Dissection, lymph node excision, excision of the lymph node
Undergo lymphadenectomy
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Irradiation, Radiotherapeutics, RT
Undergo radiation therapy
Abiraterone AcetateDrug
Also called 154229-18-2, Yonsa, Zytiga, Androsta-5
Given PO
PrednisoneDrug
Also called Deltasone, Prednicort, Prednisone Intensol, Rayos
Given PO
Computed TomographyProcedure or surgery
Also called CAT Scan, CAT, computerized axial tomography, computerized tomography
Undergo fluciclovine PET/CT
AbirateroneDrug
Also called 154229-19-3, 17-(3-Pyridyl)androsta-5, 16-dien-3beta-ol, CB 7598
Given PO
PSMA PET ScanProcedure or surgery
Also called Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography
Undergo PSMA PET scan
| Study group | Role | What they receive |
|---|---|---|
| Group I (fluciclovine PET/CT) | Active comparator | 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. Receives: Procedure: Positron Emission Tomography; Procedure: Computed Tomography; Procedure: PSMA PET Scan |
| Group II (surgery, radiotherapy, abiraterone, prednisone) | Experimental | 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. Receives: Procedure: Positron Emission Tomography; Procedure: Lymphadenectomy; Radiation: Radiation Therapy; Drug: Abiraterone Acetate; Drug: Prednisone; Procedure: Computed Tomography; Drug: Abiraterone; Procedure: PSMA PET Scan |
| Group III (abiraterone, prednisone) | Experimental | Patients undergo fluciclovine or PSMA PET/CT and who have > 3 regions of metastatic disease receive abiraterone acetate and prednisone as in Group II. Receives: Procedure: Positron Emission Tomography; Drug: Abiraterone Acetate; Drug: Prednisone; Procedure: Computed Tomography; Drug: Abiraterone; Procedure: PSMA PET Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undetectable PSA (< 0.2 ng/mL) rate
Measured: At 2 years
Secondary outcomes (6)
Total testosterone
Measured: Up to 7 years
Median time to reinitiation of antiandrogen therapy (ADT)
Measured: Up to 7 years
Overall survival
Measured: Up to 7 years
Number of patients with abnormalities within the prostatic fossa with PSA < 10 ng/mL
Measured: Up to 7 years
Number of patients without abnormalities with PSA < 10 ng/mL
Measured: Up to 7 years
Number of patients with PSA < 10 mg/mL and > 3 regions of metastatic prostate cancer on fluciclovine PET/CT
Measured: Up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start30 Sep 2020
- Primary completion1 Jul 2032 (estimated)
- Study completion1 Jul 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Responsible party
- Sponsor
- Investigators
- Evan Yu, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175431
- Sponsor's protocol ID
- RG1004972
- Other IDs
- NCI-2019-07437, 10349
- Status last verified
- Jul 2026
- First submitted
- 7 Nov 2019
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Specific Membrane Antigen (PSMA) or Fluciclovine (FACBC) PET/CT Site-Directed Therapy of OLigometASTatic Prostate Cancer (P-Flu-BLAST-PC): A Multicenter Study
- ClinicalTrials.gov ID
- NCT04175431
- Acronym / sponsor ID
- RG1004972
- Conditions
- Prostate Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 1 Jul 2032 (estimated)
- Study completion
- 1 Jul 2037 (estimated)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OUTLINE: Patients are assigned to 1 of 3 groups.
GROUP I: 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.
GROUP II: 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 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 of abiraterone acetate and prednisone.
GROUP III: Patients undergo fluciclovine or PSMA 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (fluciclovine PET/CT) | Active comparator | Procedure: Positron Emission Tomography, Procedure: Computed Tomography, Procedure: PSMA PET ScanPatients 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. |
| Group II (surgery, radiotherapy, abiraterone, prednisone) | Experimental | Procedure: Positron Emission Tomography, Procedure: Lymphadenectomy, Radiation: Radiation Therapy, Drug: Abiraterone Acetate, Drug: Prednisone, Procedure: Computed Tomography, Drug: Abiraterone, Procedure: PSMA PET ScanPatients 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. |
| Group III (abiraterone, prednisone) | Experimental | Procedure: Positron Emission Tomography, Drug: Abiraterone Acetate, Drug: Prednisone, Procedure: Computed Tomography, Drug: Abiraterone, Procedure: PSMA PET ScanPatients undergo fluciclovine or PSMA PET/CT and who have > 3 regions of metastatic disease receive abiraterone acetate and prednisone as in Group II. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positron Emission TomographyAlso: Medical Imaging, PET Scan, positron emission tomography scan, proton magnetic resonance spectroscopic imagingUndergo fluciclovine PET/CT | Procedure or surgery | Group I (fluciclovine PET/CT), Group II (surgery, radiotherapy, abiraterone, prednisone), Group III (abiraterone, prednisone) |
| LymphadenectomyAlso: Lymph Node Dissection, lymph node excision, excision of the lymph nodeUndergo lymphadenectomy | Procedure or surgery | Group II (surgery, radiotherapy, abiraterone, prednisone) |
| Radiation TherapyAlso: Cancer Radiotherapy, Irradiation, Radiotherapeutics, RTUndergo radiation therapy | Radiation | Group II (surgery, radiotherapy, abiraterone, prednisone) |
| Abiraterone AcetateAlso: 154229-18-2, Yonsa, Zytiga, Androsta-5Given PO | Drug | Group II (surgery, radiotherapy, abiraterone, prednisone), Group III (abiraterone, prednisone) |
| PrednisoneAlso: Deltasone, Prednicort, Prednisone Intensol, RayosGiven PO | Drug | Group II (surgery, radiotherapy, abiraterone, prednisone), Group III (abiraterone, prednisone) |
| Computed TomographyAlso: CAT Scan, CAT, computerized axial tomography, computerized tomographyUndergo fluciclovine PET/CT | Procedure or surgery | Group I (fluciclovine PET/CT), Group II (surgery, radiotherapy, abiraterone, prednisone), Group III (abiraterone, prednisone) |
| AbirateroneAlso: 154229-19-3, 17-(3-Pyridyl)androsta-5, 16-dien-3beta-ol, CB 7598Given PO | Drug | Group II (surgery, radiotherapy, abiraterone, prednisone), Group III (abiraterone, prednisone) |
| PSMA PET ScanAlso: Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomographyUndergo PSMA PET scan | Procedure or surgery | Group I (fluciclovine PET/CT), Group II (surgery, radiotherapy, abiraterone, prednisone), Group III (abiraterone, prednisone) |
Primary outcome
Undetectable PSA (< 0.2 ng/mL) rate
Time frame: At 2 years
6 secondary outcomes
Total testosterone
Time frame: Up to 7 years
Median time to reinitiation of antiandrogen therapy (ADT)
Time frame: Up to 7 years
Overall survival
Time frame: Up to 7 years
Number of patients with abnormalities within the prostatic fossa with PSA < 10 ng/mL
Time frame: Up to 7 years
Number of patients without abnormalities with PSA < 10 ng/mL
Time frame: Up to 7 years
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Evan Yu principal investigator
Fred Hutch/University of Washington Cancer Consortium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Positron Emission Tomography, Lymphadenectomy and Radiation Therapy in people with Prostate Adenocarcinoma, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jane Romani (206-606-1909, jromani@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Undetectable PSA (< 0.2 ng/mL) rate (time frame: At 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.