Fluciclovine PET/CT Imaging for Prostate Cancer

Recruiting at 1 trial location

Overseen By Heather Jacene, MD

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Other malignancy, Allergic reactions, Uncontrolled illness, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is studying a positron emission tomography (PET) agent called 18F-fluciclovine to evaluate how well 18F-fluciclovine-PET scans determine the extent of advanced prostate cancer that either has low prostate-specific membrane antigen (PSMA) expression or has neuroendocrine features. The name of the study interventions are: * 18F-fluciclovine-PET/CT scan * Two research blood collections

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/CT is effective in detecting prostate cancer, especially in cases of suspected recurrence after initial treatment. It helps in accurately identifying cancerous areas, which can improve treatment planning and outcomes. ^{1 2 3 4 5}

Is 18F-fluciclovine PET/CT imaging safe for humans?

Research suggests that 18F-fluciclovine PET imaging is safe and well-tolerated in humans, with studies indicating it is effective for detecting prostate cancer recurrence. ^{1 2 3 6 7}

How is the drug Fluciclovine PET/CT unique for prostate cancer?

Fluciclovine PET/CT is unique because it uses a special imaging tracer, 18F-fluciclovine, to detect prostate cancer recurrence by highlighting cancerous tissues in the body. This method is particularly useful for men who have elevated prostate-specific antigen levels after previous treatment, helping to identify cancer spread more accurately than some traditional imaging techniques. ^{1 2 3 6 8}

Research Team

Heather Jacene

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for men aged 18 or older with advanced prostate cancer that has spread and shows low PSMA levels or neuroendocrine features. They must have a decent performance status, be able to follow the study procedures, and agree to use contraception. Those with uncontrolled illnesses, severe claustrophobia, other cancers needing treatment, or allergies to similar compounds cannot join.

Inclusion Criteria

I can take care of myself but might not be able to do active work.

Ability and willingness to comply with the study procedures.

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

I have another cancer that needs treatment.

I am allergic to substances similar to 18F-fluciclovine.

I do not have any serious illnesses that would stop me from following the study's requirements.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Blood Collection

Participants receive 18F-fluciclovine PET/CT scan and two research blood collections

6 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

up to 6 months

Treatment Details

Interventions

• 18F-fluciclovine

Trial Overview The study tests how well an imaging agent called 18F-fluciclovine works in PET/CT scans for detecting advanced prostate cancer with specific characteristics. Participants will undergo the special scan and provide two blood samples for research purposes.

Participant Groups

Group I: 18F-fluciclovine Experimental Treatment 2 Interventions

Participants with low prostate-specific membrane antigen (PSMA) expression or neuroendocrine prostate cancer will receive: * 18F-fluciclovine PET/CT within 6 weeks of standard of care exam and 68Ga-PSMA PET/CT * 2x Blood test at time of 18F-fluciclovine PET/CT and prior to treatment as determined by participants primary oncologist

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Blue Earth Diagnostics, Inc

Collaborator

Trials

5

Recruited

160+

Blue Earth Diagnostics

Industry Sponsor

Trials

43

Recruited

3,100+

Findings from Research

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 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 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 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]

In a study of 165 men with biochemical recurrence of prostate cancer, 18F-fluciclovine PET/CT demonstrated a high positivity rate of 67%, which increased with higher prostate-specific antigen (PSA) levels, indicating its effectiveness in detecting recurrence.

The use of 18F-fluciclovine PET/CT led to changes in clinical management for 62% of patients, including localization of lesions that were missed by conventional imaging, highlighting its clinical utility in guiding treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Clinical Utility of 18F-Fluciclovine PET/CT in Biochemically Recurrent Prostate Cancer: an Academic Center Experience Post FDA Approval. Nakamoto, R., Harrison, C., Song, H., et al.[2022]

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]

18F-fluciclovine (Axumin) PET imaging is safe and well-tolerated, showing good sensitivity and specificity for detecting prostate cancer recurrence after initial treatment, based on a systematic review of 18 relevant studies.

This imaging technique may be more effective than other PET radiotracers like ProstaScint and 11C-choline, potentially aiding in treatment planning for patients with biochemical recurrence of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluciclovine positron emission tomography in the setting of biochemical recurrence following local therapy of prostate cancer. Glaser, ZA., Rais-Bahrami, S.[2020]

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. 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]

2. 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]

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

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

4. 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]

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

The Clinical Utility of 18F-Fluciclovine PET/CT in Biochemically Recurrent Prostate Cancer: an Academic Center Experience Post FDA Approval. [2022]

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

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

7. China pubmed.ncbi.nlm.nih.gov

Fluciclovine positron emission tomography in the setting of biochemical recurrence following local therapy of prostate cancer. [2020]

8. 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]