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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging technique to track prostate cancer that has spread and resists standard hormone therapy. The study employs a special scan called 18F-Fluciclovine PET/CT (also known as Axumin) to capture images of the cancer before and during treatment with a specific therapy. The goal is to determine if these scans provide better information about the cancer's response to treatment. Veterans with prostate cancer unresponsive to hormone treatment and willing to undergo several scans might be suitable for this trial. As a Phase 4 trial, this research involves an FDA-approved treatment, aiming to understand its benefits for more patients.

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 is the safety track record for 18F-Fluciclovine?

Research has shown that 18F-Fluciclovine, also known as Axumin, is usually well-tolerated by patients. The FDA has approved this substance for detecting recurrent prostate cancer. Studies have found it to be safe, with only minor side effects. Most patients did not experience significant side effects; those who did reported mild ones, such as pain at the injection site or headaches. This safety information comes from its use in past clinical settings for monitoring prostate cancer. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The treatment 18F-Fluciclovine is unique because it uses a special radioactive tracer for PET/CT scans to detect prostate cancer more accurately. Unlike conventional imaging methods like bone scans or CT scans, which can miss small or hidden tumors, 18F-Fluciclovine PET/CT offers enhanced sensitivity and specificity, potentially identifying cancer spread earlier. Researchers are excited about this treatment because it could lead to better, more personalized treatment plans by providing clearer images of cancer activity in the body.

What evidence suggests that this imaging technique is effective for prostate cancer?

Research has shown that 18F-Fluciclovine, also known as Axumin, effectively images prostate cancer by highlighting cancer cells, which absorb more of certain amino acids. Studies have found that this imaging agent helps detect recurrent prostate cancer, especially in men with rising PSA levels after surgery or radiation. This trial will use 18F-Fluciclovine PET/CT scans to provide a clearer picture of prostate cancer activity. The accuracy of these scans can lead to better treatment decisions for prostate cancer patients. Overall, this imaging tool reliably assesses prostate cancer. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6910635/

Update on 18F-Fluciclovine PET for Prostate Cancer Imaging The tumor-imaging features of this radiotracer mirror the upregulation of transmembrane amino acid transport that occurs in prostate cancer ...

2. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/rg.2019180139

Review of 18F-Fluciclovine PET for Detection of Recurrent ... The clinical pharmacology and imaging features of FACBC are reviewed, and the role of this agent in the imaging of recurrent prostate cancer, within the context ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/60/11/1531

18F-Fluciclovine Parameters on Targeted Prostate Biopsy ... We evaluated 18F-fluciclovine uptake parameters that correlate with true positivity for local recurrence in non–prostatectomy-treated patients.

4. axumin.com axumin.com/about/efficacy

Axumin® (fluciclovine F 18) injection | Axumin Efficacy Data Review data from 2 Axumin studies in men with suspected recurrent prostate cancer based on rising PSA levels following prostatectomy and/or radiotherapy.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4844004/

Anti-1-Amino-3-18F-Fluorocyclobutane-1-Carboxylic Acid At our institutions, we have also obtained 18F-FACBC scans in clinical trials involving prostate cancer and other neoplasms. The purpose of this study was to ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2016/208054s000lbl.pdf

AXUMIN (fluciclovine F 18) injection, for intravenous use The safety and efficacy of Axumin were evaluated in two studies (Study 1 and Study 2) in men with suspected recurrence of prostate cancer based on rising PSA ...

7. axumin.com axumin.com/

Axumin® (fluciclovine F 18) injection | For Healthcare ... Confirmed. Axumin® (fluciclovine F 18) detects and locates suspected prostate cancer recurrence in your patients with elevated PSA after prior treatment.

8. go.drugbank.com go.drugbank.com/drugs/DB13146

Fluciclovine (18F): Uses, Interactions, Mechanism of Action Fluciclovine is indicated as a detection agent for positron emission tomography (PET) in men with suspected prostate cancer recurrence.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S187887501831711X

Fluciclovine, Anti-1-Amino-3-[18F]-Fluorocyclobutane- ... Fluciclovine is a novel PET radiotracer recently approved by the FDA for prostate cancer surveillance. · To our knowledge, these are the first reported cases of ...