Prostatic NeoplasmsPhase 4NCT06706921
18F-Fluciclovine PET/CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer
A Phase 4 study testing 18F-Fluciclovine PET/CT Scan in people with Prostatic Neoplasms and Prostatic Neoplasms, Castration-Resistant, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
Trial summary
This a single-center, prospective, exploratory study. Patients with metastatic castration-resistant prostate cancer (mCRPC) scheduled to undergo Lutetium labelled prostate-specific membrane antigen radioligand therapy (LuPSMA RLT) at the West Los Angeles VA (WLA-VA) will be imaged with a baseline F-18… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Prostatic Neoplasms, Castration-Resistant, Metastatic Prostate Cancer
- What is being tested?
- 18F-Fluciclovine PET/CT Scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2024to 1 Nov 2027
- Phase
- Phase 4
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
- Patients with mCRPC scheduled to undergo LuPSMA RLT.
- Willingness to undergo multiple serial PET/CT scans pre- and post-LuPSMA RLT.
- Ability of providing written informed consent.
Who cannot join
- Less than 18 years-old at the time of radiopharmaceutical administration.
- Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance.
- Contraindications to LuPSMA RLT.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
Gholam Berenji, MD, 310-268-3547, gholam.berenji@va.gov
Janake Wijesuriya, BS, 310-977-5209, Janake.Wijesuriya@va.gov
About this study
Official title: Usefulness of Tumor Heterogeneity Assessment in Patients With MCRPC Undergoing Radioligand Therapy With 177LU-PSMA-617 Using Serial 18F-DCFPYL, 18F-FDG and 18F-Fluciclovine PET/CT Predicting Clinical Outcome
This a single-center, prospective, exploratory study. Patients with metastatic castration-resistant prostate cancer (mCRPC) scheduled to undergo Lutetium labelled prostate-specific membrane antigen radioligand therapy (LuPSMA RLT) at the West Los Angeles VA (WLA-VA) will be imaged with a baseline F-18 fluorodeoxyglucose positron emission tomography/computed tomography 18F-FDG PET/CT and a 18F-DCFPyL PET/CT (18F-DCFPyL (2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid)positron emission tomography/computed tomography , as per standard of care in our institution. All patients further undergo eventual follow-up prostate-specific membrane antigen positron emission tomography (PSMA PET) after the 2nd, 4th, and 6th LuPSMA RLT cycle. In this prospective study, an18F-Fluciclovine positron emission tomography/computed tomography ( Axumin PET/CT )will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles. Axumin PET/CT will be acquired within 7 days from the PSMA PET.
This study is open to Veterans only.
Read the detailed description
The imaging analysis will consist in obtaining quantitative measurements of lesion uptake on the pre- and post-LuPSMA RLT (lesion and whole-body SUVmax, SUVmean and tumor volume) at each time point on all PET/CT scans. PET metrics at the lesion- and whole-body level will be compared among different PET radiopharmaceuticals at the same time point, and changes over time will be assessed.
All patients will be followed-up at our institution and clinical outcome will be correlated to the imaging analysis assessment.
- Conditions
- Prostatic Neoplasms, Prostatic Neoplasms, Castration-Resistant, Metastatic Prostate Cancer, Male Urogenital Diseases, Prostatic Diseases, Urogenital Diseases, Male
- Being tested
- 18F-Fluciclovine PET/CT Scan
- Keywords
- Prostate cancer, PET/CT, Radioligand Therapy, Metastatic Castration-Resistant Prostate Cancer, PSMA PET
- Medical subject headings
- Prostatic Neoplasms, Prostatic Neoplasms, Castration-Resistant, Male Urogenital Diseases, Prostatic Diseases, Genital Diseases, Male, Neoplasms, Neoplasms by Site, Urogenital Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-Fluciclovine PET/CT ScanDrug
In this prospective study, an 18F-Fluciclovine PET/CT will be additionally obtained at baseline (pre-LuPSMA RLT), and after the 2nd, 4th, 6th LuPSMA RLT cycles.18F-Fluciclovine PET/CT will be acquired within 7 days from the PSMA PET.
| Study group | Role | What they receive |
|---|---|---|
| 18F-Fluciclovine PET/CT | Experimental | Subjects receive 18F-Fluciclovine PET/CT scans. Receives: Drug: 18F-Fluciclovine PET/CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
18F-Fluciclovine PET/CT Impact on Predicting Clinical Outcome of 177Lu-PSMA-617 Therapy in Patients With Prostate Cancer
Whole-body and lesion-level SUVmean, SUVmax. SUVmax, or maximum standardized uptake value, is a measurement used in positron emission tomography (PET) scans to quantify how much glucose a tumor is metabolizing.
Measured: From enrollment to end of treatment at 34 weeks.
Secondary outcomes (1)
Usefulness of Tumor Heterogeneity Assessment in Patients in Patients With MCRPC Undergoing Radioligand Therapy With 177LU-PSMA-617 Using Serial 18F-DCFPYL, 18F-FDG and 18F-Fluciclovine PET/CT Predicting Clinical Outcome.
Tumor volume on FDG, Axumin and DCFPyL PET/CT. Tumor volume is the amount of space a tumor occupies, measured in cubic centimeters (cc).
Measured: From enrollment to end of treatment at 34 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start15 Dec 2024 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Greater Los Angeles Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Gholam Reza Berenji, MD, VA Greater Los Angeles Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706921
- Sponsor's protocol ID
- 1819674
- Status last verified
- Sep 2024
- First submitted
- 22 Oct 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study results are unknown at this time. The plan will be reevaluated once the results come in.