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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special type of scan, called 18F-fluciclovine PET/CT, to better understand the spread of advanced prostate cancer, particularly when the cancer shows low levels of a certain protein (PSMA) or has neuroendocrine features. The goal is to determine if this scan provides clearer images of the cancer compared to usual methods. It targets individuals with prostate cancer that has spread and either exhibits low PSMA levels or specific neuroendocrine traits. Participants must have already undergone or plan to undergo a standard PET/CT scan as part of their care. As a Phase 1 trial, this research aims to understand how the scan functions in people, offering participants a chance to be among the first to benefit from this innovative imaging technology.

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 prior data suggests that the 18F-fluciclovine-PET/CT scan is safe for evaluating prostate cancer?

Research has shown that 18F-fluciclovine is generally safe for people. In past studies, patients who underwent scans with this PET agent reported only a few side effects. Its approval for detecting recurrent prostate cancer suggests its safety. So far, no major adverse reactions have been reported, indicating that the treatment appears safe for most participants in trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 18F-fluciclovine PET/CT imaging for prostate cancer because it offers a unique way to visualize cancer that might not show up well with standard options like 68Ga-PSMA PET/CT scans. Unlike most imaging techniques, which primarily target the prostate-specific membrane antigen (PSMA), 18F-fluciclovine targets amino acid transport, potentially revealing cancers with low PSMA expression or neuroendocrine differentiation. This means it could catch certain prostate cancers that are easily missed, leading to better diagnosis and treatment planning.

What evidence suggests that the 18F-fluciclovine-PET/CT scan is effective for evaluating advanced prostate cancer?

Research has shown that 18F-fluciclovine, which participants in this trial will receive, effectively detects prostate cancer. Studies indicate that this imaging agent identifies cancer in about 81% of cases. It is already approved for identifying recurrent prostate cancer in patients with rising PSA levels. The use of 18F-fluciclovine PET/CT scans has influenced how doctors manage and treat the condition, with many patients experiencing changes in their treatment plans based on scan results. These findings suggest that 18F-fluciclovine could be useful for assessing prostate cancer, especially when other indicators are low. ^{6 7 8 9 10}

Who Is on the Research Team?

Heather Jacene

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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 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 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]

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]

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]

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]

Citations

1. axumin.com axumin.com/about/efficacy

Axumin® (fluciclovine F 18) injection | Axumin Efficacy Data Axumin demonstrated an overall (whole-body) detection rate of 81% · 61% (92) had positive findings within the prostate and prostate bed · 55% (83) had positive ...

2. nature.com nature.com/articles/s41391-021-00382-9

18F-Fluciclovine PET/CT performance in biochemical ... F-Fluciclovine PET/CT was shown to impact patient management and outcomes. Two studies reported 59–63% of patients to have a management change ...

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

Update on 18F-Fluciclovine PET for Prostate Cancer Imaging 18 F-fluciclovine is FDA-approved for the localization of recurrent prostate cancer in patients with elevated PSA levels.

4. jnm.snmjournals.org jnm.snmjournals.org/content/63/supplement_2/4075

Analysis of Prostate Cancer Imaging Agents: F-18 Fluciclovine ... Results: Overall, PSMA was able to detect a greater number of lesions than Axumin in patients that had undergone both scans. However, PSMA also ...

5. urotoday.com urotoday.com/conference-highlights/astro-2025/astro-2025-prostate-cancer/163506-astro-2025-patient-reported-outcomes-in-a-randomized-trial-of-18f-fluciclovine-vs-68ga-psma-11-pet-ct-guided-post-prostatectomy-radiation-with-simultaneous-integrated-boosts.html

Patient-Reported Outcomes in a Randomized Trial of 18F ... Similarly, pelvic nodal boosts were delivered in 60% of evaluable patients in the fluciclovine arm and 41.2% in the PSMA arm, with consistent median doses of ...

6. axumin.com axumin.com/about/clinical-utility

Axumin LOCATE Trial Results Detection rate increased as PSA level rose​​ Axumin-avid lesions were detected in 57% of patients (122/213) who had a negative equivocal finding on standard-of- ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2016/208054Orig1s000CrossR.pdf

208054Orig1s000 - accessdata.fda.gov The efficacy of fluciclovine was based on re-analyses of data from two prospective studies in men with suspected recurrence of prostate cancer.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5645081/

Multisite Experience of the Safety, Detection Rate and ... Fluciclovine (18F) is well tolerated and able to detect local and distant prostate cancer recurrence across a wide range of prostate specific antigen values.

9. ema.europa.eu ema.europa.eu/en/documents/product-information/axumin-epar-product-information_en.pdf

Axumin, INN-fluciclovine18F - EMA Axumin is indicated for positron emission tomography (PET) imaging to detect recurrence of prostate cancer in adult men with a suspected recurrence based on ...

10. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2016/208054Orig1s000ODMemo.pdf

208054Orig1s000 - accessdata.fda.gov The evidence in this application supports efficacy of fluciclovine F18 for detection of prostate cancer recurrence in men with elevated PSA ...