Imaging Scans for Prostate Cancer

Overseen By Janake Wijesuriya, BS

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: VA Greater Los Angeles Healthcare System

Disqualifiers: Under 18, Serious illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 34 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the drug 18F-Fluciclovine (Axumin) for prostate cancer?

Research shows that 18F-Fluciclovine PET imaging is promising for detecting and characterizing prostate cancer, especially in identifying small lymph node metastases. It has been approved for use in men with suspected prostate cancer recurrence, indicating its effectiveness in improving diagnosis and surveillance. ^{1 2 3 4 5}

Is 18F-Fluciclovine (Axumin) safe for use in humans?

18F-Fluciclovine (Axumin) has been approved by the US Food and Drug Administration for use in men with suspected prostate cancer recurrence, indicating it has been evaluated for safety in humans. ^{2 5 6 7 8}

How does the imaging treatment for prostate cancer differ from other treatments?

The imaging treatment for prostate cancer using 18F-fluciclovine PET/CT (Axumin) is unique because it helps detect prostate cancer recurrence by highlighting areas of increased metabolic activity, which is different from traditional imaging methods that may not be as sensitive in identifying cancerous tissues. This approach is particularly useful for patients with elevated prostate-specific antigen levels after previous treatment. ^{2 5 6 7 9}

Eligibility Criteria

This trial is specifically for veterans with metastatic castration-resistant prostate cancer (mCRPC) who are scheduled to receive LuPSMA RLT at the West Los Angeles VA. Participants must be able to undergo multiple PET/CT scans.

Inclusion Criteria

I am scheduled for LuPSMA therapy for my prostate cancer.

I am willing to have several PET/CT scans before and after LuPSMA RLT treatment.

Ability of providing written informed consent

Exclusion Criteria

I am under 18 years old.

Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance

I have no health conditions that prevent me from receiving LuPSMA RLT.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Baseline F-18 FDG PET/CT and 18F-DCFPyL PET/CT scans are performed as per standard of care

1 week

1 visit (in-person)

Treatment

Patients undergo Lutetium labelled prostate-specific membrane antigen radioligand therapy (LuPSMA RLT) with imaging assessments after the 2nd, 4th, and 6th cycles

34 weeks

Multiple visits (in-person) for therapy and imaging

Follow-up

Participants are monitored for safety and effectiveness after treatment, with clinical outcomes correlated to imaging analysis

4 weeks

Treatment Details

Interventions

• 18F-Fluciclovine

Trial Overview The study is exploring how an additional scan called 18F-Fluciclovine PET/CT can predict the outcome of a therapy called LuPSMA RLT in patients with advanced prostate cancer. It's a single-center, prospective study comparing standard scans with this new imaging technique over several treatment cycles.

Participant Groups

Group I: 18F-Fluciclovine PET/CT Experimental Treatment 1 Intervention

Subjects receive 18F-Fluciclovine PET/CT scans.

Who Is Running the Clinical Trial?

VA Greater Los Angeles Healthcare System

Lead Sponsor

Trials

53

Recruited

8,700+

Findings from Research

Prostate cancer is the most common cancer in men and poses significant challenges for diagnosis and monitoring due to its often slow-growing nature.

The use of F-18 fluciclovine PET imaging enhances the detection of prostate cancer by targeting the increased transport of amino acids, which is upregulated in cancer cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of Prostate Cancer Using Fluciclovine. Savir-Baruch, B., Zanoni, L., Schuster, DM.[2017]

In a study involving 28 patients with high-risk primary prostate cancer, late-window [18F]Fluciclovine PET imaging (specifically at 33-38 minutes post-injection) was found to be significantly better at distinguishing between malignant and benign prostate tissues compared to early imaging (5-10 minutes post-injection).

The late imaging window also effectively assessed tumor aggressiveness, showing differences in uptake values between high-grade and low/intermediate-grade tumors, indicating its potential for improving prostate cancer diagnosis and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A PET/MRI study towards finding the optimal [18F]Fluciclovine PET protocol for detection and characterisation of primary prostate cancer. Elschot, M., Selnæs, KM., Sandsmark, E., et al.[2018]

In a phase II clinical trial involving 28 prostate cancer patients, 18F-fluciclovine PET/CT demonstrated a sensitivity of 57.1% for detecting small lymph node metastases, indicating it can identify some metastatic lesions effectively, particularly those with larger sizes and higher cancer volumes.

The test showed good specificity (84.8%) and negative predictive value (90.3%), suggesting it is reliable in ruling out metastases, but it also had limitations, as it produced positive results in some benign lymph nodes, highlighting the need for improved assessment criteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance of 18F-fluciclovine PET/CT for regional lymph node metastases in patients with primary prostate cancer: a multicenter phase II clinical trial. Suzuki, H., Jinnouchi, S., Kaji, Y., et al.[2020]

F-18 fluciclovine PET imaging is a promising technique for detecting prostate cancer due to its ability to highlight amino acid transport, which is increased in cancer cells.

The imaging method shows normal uptake patterns in the liver and pancreas with minimal urine excretion, making it particularly advantageous for accurately visualizing prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of Prostate Cancer Using Fluciclovine. Savir-Baruch, B., Zanoni, L., Schuster, DM.[2018]

The PET tracer 18F-fluciclovine (Axumin) has been approved for use in men suspected of having recurrent prostate cancer after previous treatment, indicating its potential role in improving diagnosis.

Studies utilizing systematic sector-based histopathology as a reference standard have been conducted to evaluate the diagnostic accuracy of 18F-fluciclovine PET, highlighting its importance in clinical settings for prostate cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-Fluciclovine PET for Assessment of Prostate Cancer with Histopathology as Reference Standard: A Systematic Review. Seierstad, T., Hole, KH., Tulipan, AJ., et al.[2021]

In a study involving 41 patients, the integration of (18)F-fluciclovine PET-CT into radiation therapy planning for prostate cancer significantly altered treatment target volumes in 83% of detected abnormalities, indicating its utility in improving treatment accuracy.

The use of (18)F-fluciclovine allowed for more precise targeting of cancerous areas, with 51% of changes occurring in lymph nodes, suggesting that this radiotracer can enhance the effectiveness of post-surgery radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image Guided Planning for Prostate Carcinomas With Incorporation of Anti-3-[18F]FACBC (Fluciclovine) Positron Emission Tomography: Workflow and Initial Findings From a Randomized Trial. Schreibmann, E., Schuster, DM., Rossi, PJ., et al.[2018]

The FDA recently approved F-labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC, F-fluciclovine) PET/CT scans for detecting suspected prostate cancer recurrence in men with elevated PSA levels after treatment.

In a unique case study of a 77-year-old man, the scan revealed not only suspected recurrent prostate cancer but also advanced-stage breast cancer, highlighting the potential for incidental findings during prostate imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metastatic Male Breast Cancer With Increased Uptake on 18F-Fluciclovine PET/CT Scan. Gill, HS., Tade, F., Greenwald, DT., et al.[2018]

In a study of 89 men with prostate cancer experiencing their first biochemical recurrence, 23.6% were found to have oligometastatic disease using 18F-fluciclovine PET/CT imaging, indicating its effectiveness in detecting early metastatic spread.

The presence of oligometastases led to a change in management for 57.1% of patients, highlighting the clinical significance of this imaging technique in guiding treatment decisions, although no significant link was found between serum PSA levels and the number of oligometastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management Impact of Metachronous Oligometastatic Disease Identified on 18F-Fluciclovine (Axumin™) PET/CT in Biochemically Recurrent Prostate Cancer. Anderson, RC., Velez, EM., Jadvar, H.[2022]

The 18 F-fluciclovine PET/CT scan effectively identified intense uptake in left adrenal gland metastasis in a prostate cancer patient, highlighting its utility in detecting visceral metastasis.

In contrast, the 18 F-NaF PET/CT scan showed intense uptake in multiple sclerotic bone metastases, indicating that both imaging techniques are necessary for a comprehensive evaluation of metastatic prostate cancer, as they provide complementary information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complementary Role of 18 F-Fluciclovine PET/CT and 18 F-NaF PET/CT in Detecting Prostate Cancer Metastasis. Xu, F., Liu, F., Chen, W.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Imaging of Prostate Cancer Using Fluciclovine. [2017]

2. Germany pubmed.ncbi.nlm.nih.gov

A PET/MRI study towards finding the optimal [18F]Fluciclovine PET protocol for detection and characterisation of primary prostate cancer. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Diagnostic performance of 18F-fluciclovine PET/CT for regional lymph node metastases in patients with primary prostate cancer: a multicenter phase II clinical trial. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Imaging of Prostate Cancer Using Fluciclovine. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

18F-Fluciclovine PET for Assessment of Prostate Cancer with Histopathology as Reference Standard: A Systematic Review. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Image Guided Planning for Prostate Carcinomas With Incorporation of Anti-3-[18F]FACBC (Fluciclovine) Positron Emission Tomography: Workflow and Initial Findings From a Randomized Trial. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Metastatic Male Breast Cancer With Increased Uptake on 18F-Fluciclovine PET/CT Scan. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Management Impact of Metachronous Oligometastatic Disease Identified on 18F-Fluciclovine (Axumin™) PET/CT in Biochemically Recurrent Prostate Cancer. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Complementary Role of 18 F-Fluciclovine PET/CT and 18 F-NaF PET/CT in Detecting Prostate Cancer Metastasis. [2023]