Metastatic Castration-resistant Prostate CancerPhase 2NCT04158245
18F-fluciclovine PET in Metastatic Castration Resistant Prostate Cancer Treated With Life Prolonging Therapies
A Phase 2 study testing 18F-fluciclovine PET Scan in people with Metastatic Castration-resistant Prostate Cancer, run by Tulane University at 1 site in United States.
Trial summary
This is a pilot phase 2 single-arm study, of men with metastatic castration-resistant prostate cancer (mCRPC). Patients will be treated with any of the approved life-prolonging therapies: abiraterone 1000 mg daily plus prednisone 5 mg (or dexamethasone 0.5 mg) daily, enzalutamide 160 mg daily, or docetaxel 50 mg/m2… Read more about this study
- Who is it for?
- Ages 18 to 18 years, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- 18F-fluciclovine PET Scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2020to 3 Apr 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 18 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2;
- Age ≥ 18 years;
- Histologically confirmed adenocarcinoma of the prostate;
- Ongoing use of luteinizing hormone-releasing hormone (LHRH) required in the absence of surgical castration and castrate concentration of testosterone (< 50 ng/dL);
- Detectable PSA of at least 2 ng/dL;
- Metastatic disease documented by CT or bone scan within 42 days of cycle 1 day 1;
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- Life expectancy of ≥ 6 months;
- Must have disease progression despite a castrate concentration of testosterone of < 50 ng/dL based on:
- PSA progression defined as increase in PSA of at least 2 ng/dL and 25% from nadir values of prior therapy, determined by 2 separate measurement taken at least 1 week apart;
- And/or
- Radiographic disease progression based on response evaluation criteria in solid tumors (RECIST) 1.1 for soft tissue disease and/or prostate cancer working group 3 (PCWG3) for bone only disease;
- No prior life-prolonging therapies for mCRPC are allowed, except Sipuleucel-T;
- The use of docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting is allowed;
- Low dose prednisone (10 mg or less) or equivalent is allowed;
- Acceptable liver function (within 28 days from enrollment) defined as:
- Bilirubin < 2.5 times upper limit of normal (ULN), except for patients with known Gilbert disease (in such cases bilirubin < 5 times ULN);
- AST (SGOT) and ALT (SGPT) < 3 times ULN
- Acceptable renal function (within 28 days from enrollment):
- Serum creatinine ≤ 2.0 x ULN or creatinine clearance ≥ 30 mL/min
- Acceptable hematologic status (within 28 days from enrollment):
- Absolute neutrophil count (ANC) ≥ 1000 cell/mm3 (100 x 109/L)
- Platelet count ≥ 100,000 platelet/mm3 (100 x 109/L)
- Hemoglobin ≥ 9 g/dL
- At least 2 weeks since prior radiation before starting study treatment (cycle 1 day 1);
- Able to understand and willing to sign a written informed consent document;
- Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last dose of abiraterone acetate.
Who cannot join
- Pathological findings consistent with small cell carcinoma of the prostate;
- Prior treatment with docetaxel for metastatic castration-resistant prostate cancer (CRPC);
- Patient with normal 18F-flucicolovine PET/CT scans at baseline;
- Know allergies, hypersensitivity, or intolerance to abiraterone, prednisone, 18F-fluciclovine or their excipients;
- Any chronic medical condition requiring ≥ 10 mg daily of systemic prednisone (or equivalent);
- Major surgery (e.g., required general anesthesia) within 2 weeks before screening;
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- Uncontrolled active infection (including hepatitis B or C or AIDS). Patients with hepatitis B/C who have disease under control and no significant liver function impairment, and undetectable viral load will be allowed to participate. Similarly, patients with known HIV and ≥ 400 CD4 + T cells are allowed to participate;
- Evidence of other metastatic malignancies within the last year;
- Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tulane Cancer Center Clinic
New Orleans, Louisiana, 70112
About this study
Official title: Changes in 18F-fluciclovine Positron Emission Tomography (PET) in Patients With Metastatic Castration Resistant Prostate Cancer Treated With With Life Prolonging Therapies: A Pilot Study
This is a pilot phase 2 single-arm study, of men with metastatic castration-resistant prostate cancer (mCRPC). Patients will be treated with any of the approved life-prolonging therapies: abiraterone 1000 mg daily plus prednisone 5 mg (or dexamethasone 0.5 mg) daily, enzalutamide 160 mg daily, or docetaxel 50 mg/m2 every two weeks or 75 mg/m2 every three weeks.
Read the detailed description
Prostate cancer is a hormonally-driven disease and androgens are key in the growth of both normal prostate and prostate cancer cells. Once mCRPC is evident, most patients receive a second-generation hormonal therapy to further suppress the synthesis or androgens (abiraterone) and to block androgen receptor (AR) activation, nuclear translocation and DNA binding (enzalutamide).
Conventional imaging of prostate cancer has limitations in staging, restaging after biochemical relapse, and response assessment. Functional imaging with positron emission tomography (PET) can target various aspects of tumor biology and is clearly superior in the detection of extra-prostatic disease. 18F-fluciclovine is a synthetic amino acid transported across mammalian cell membranes by amino acid transporters that are upregulated in prostate cancer cells.
18F-fluciclovine is approved for PET imaging to identify sites of prostate cancer recurrence in men with rising prostate specific antigen (PSA) following prior definitive treatment. This study describes the changes in 18F-fluciclovine PET scan and compare these results with PSA and conventional computerized tomography (CT) and bone scans, in mCRPC patients treated with abiraterone acetate-prednisone, enzalutamide or docetaxel.
- Being tested
- 18F-fluciclovine PET Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-fluciclovine PET ScanDrug
Also called Axumin
The use of 18F-fluciclovine PET scanning will allow a more sensitive assessment of mCRPC patients at the initiation of systemic therapy and changes observed in 18F-fluciclovine PET will correlate better with the serologic changes in PSA, allowing superior disease monitoring, as compared to conventional imaging modalities. In addition, 18F-fluciclovine PET will detect heterogeneity in disease response and thus identify potential lesions amenable to targeted therapy.
| Study group | Role | What they receive |
|---|---|---|
| 18F-fluciclovine PET Scan | Experimental | Single intravenous administration of 18F-fluciclovine for PET Scan. Receives: Drug: 18F-fluciclovine PET Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in 18F-fluciclovine PET Scan for Patients With mCRPC on Treatment With Life Prolonging Therapies
To describe the 18F-fluciclovine PET findings for patients with mCRPC prior to starting treatment with Life Prolonging Therapies, and at 12 weeks after Life Prolonging Therapies treatment initiation. We have 4 categories that can be seen in the scan to measure the metabolic response using PERSIST 1.1, 1)stable disease, 2)progressive disease, 3)partial response and 4)complete response.
Measured: 12 weeks
PET Scan vs. Conventional CT and Bone Scan
A comparison of 18F-fluciclovine PET with conventional CT and bone scans for patients with mCRPC prior to starting treatment with life prolonging therapies, and at 12 weeks after starting life prolonging therapies; and to correlate these changes with PSA response and progression after starting life prolonging therapies.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start30 Jan 2020
- Primary completion30 Sep 2022
- Study completion3 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Describe the changes in the 18F-fluciclovine Positron Emission Tomography (PET) in patients with metastatic castration resistant prostate cancer treated with abiraterone acetate-prednisone, enzalutamide or docetaxel.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Responsible party
- Sponsor
- Investigators
- Brian Lewis, MD, MPH, FACP, Principal investigator, Tulane University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158245
- Sponsor's protocol ID
- BED-IIT-382
- Status last verified
- Feb 2025
- First submitted
- 6 Nov 2019
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in 18F-fluciclovine Positron Emission Tomography (PET) in Patients With Metastatic Castration Resistant Prostate Cancer Treated With With Life Prolonging Therapies: A Pilot Study
- ClinicalTrials.gov ID
- NCT04158245
- Acronym / sponsor ID
- BED-IIT-382
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 3 Apr 2023 (actual)
- First posted
- 8 Nov 2019 (actual)
- Results
- Posted 22 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot phase 2 single-arm study, of men with metastatic castration-resistant prostate cancer (mCRPC). Patients will be treated with any of the approved life-prolonging therapies: abiraterone 1000 mg daily plus prednisone 5 mg (or dexamethasone 0.5 mg) daily, enzalutamide 160 mg daily, or docetaxel 50 mg/m2 every two weeks or 75 mg/m2 every three weeks.
Detailed description
Prostate cancer is a hormonally-driven disease and androgens are key in the growth of both normal prostate and prostate cancer cells. Once mCRPC is evident, most patients receive a second-generation hormonal therapy to further suppress the synthesis or androgens (abiraterone) and to block androgen receptor (AR) activation, nuclear translocation and DNA binding (enzalutamide).
Conventional imaging of prostate cancer has limitations in staging, restaging after biochemical relapse, and response assessment. Functional imaging with positron emission tomography (PET) can target various aspects of tumor biology and is clearly superior in the detection of extra-prostatic disease. 18F-fluciclovine is a synthetic amino acid transported across mammalian cell membranes by amino acid transporters that are upregulated in prostate cancer cells.
18F-fluciclovine is approved for PET imaging to identify sites of prostate cancer recurrence in men with rising prostate specific antigen (PSA) following prior definitive treatment. This study describes the changes in 18F-fluciclovine PET scan and compare these results with PSA and conventional computerized tomography (CT) and bone scans, in mCRPC patients treated with abiraterone acetate-prednisone, enzalutamide or docetaxel.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Describe the changes in the 18F-fluciclovine Positron Emission Tomography (PET) in patients with metastatic castration resistant prostate cancer treated with abiraterone acetate-prednisone, enzalutamide or docetaxel.
| Arm | Type | Receives |
|---|---|---|
| 18F-fluciclovine PET Scan | Experimental | Drug: 18F-fluciclovine PET ScanSingle intravenous administration of 18F-fluciclovine for PET Scan. |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (26 listed)
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2;
- Age ≥ 18 years;
- Histologically confirmed adenocarcinoma of the prostate;
- Ongoing use of luteinizing hormone-releasing hormone (LHRH) required in the absence of surgical castration and castrate concentration of testosterone (< 50 ng/dL);
- Detectable PSA of at least 2 ng/dL;
Key exclusion criteria (9 listed)
- Pathological findings consistent with small cell carcinoma of the prostate;
- Prior treatment with docetaxel for metastatic castration-resistant prostate cancer (CRPC);
- Patient with normal 18F-flucicolovine PET/CT scans at baseline;
- Know allergies, hypersensitivity, or intolerance to abiraterone, prednisone, 18F-fluciclovine or their excipients;
- Any chronic medical condition requiring ≥ 10 mg daily of systemic prednisone (or equivalent);
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 |
|---|---|---|
| 18F-fluciclovine PET ScanAlso: AxuminThe use of 18F-fluciclovine PET scanning will allow a more sensitive assessment of mCRPC patients at the initiation of systemic therapy and changes observed in 18F-fluciclovine PET will correlate better with the serologic changes in PSA, allowing superior disease monitoring, as compared to conventional imaging modalities. In addition, 18F-fluciclovine PET will detect heterogeneity in disease response and thus identify potential lesions amenable to targeted therapy. | Drug | 18F-fluciclovine PET Scan |
Primary outcome
Changes in 18F-fluciclovine PET Scan for Patients With mCRPC on Treatment With Life Prolonging Therapies
Time frame: 12 weeks
To describe the 18F-fluciclovine PET findings for patients with mCRPC prior to starting treatment with Life Prolonging Therapies, and at 12 weeks after Life Prolonging Therapies treatment initiation. We have 4 categories that can be seen in the scan to measure the metabolic response using PERSIST 1.1, 1)stable disease, 2)progressive disease, 3)partial response and 4)complete response.
PET Scan vs. Conventional CT and Bone Scan
Time frame: 12 weeks
A comparison of 18F-fluciclovine PET with conventional CT and bone scans for patients with mCRPC prior to starting treatment with life prolonging therapies, and at 12 weeks after starting life prolonging therapies; and to correlate these changes with PSA response and progression after starting life prolonging therapies.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Metastatic Castration-resistant Prostate Cancer
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RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
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. This study is not recruiting at the moment.
Brian Lewis, MD, MPH, FACP principal investigator
Tulane University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-fluciclovine PET Scan in people with Metastatic Castration-resistant Prostate Cancer, run by Tulane University at 1 site 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 26 inclusion and 9 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: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 22 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in 18F-fluciclovine PET Scan for Patients With mCRPC on Treatment With Life Prolonging Therapies (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 22 Sep 2025.