PET/CT Scan with Tracers for Prostate Cancer

Recruiting at 2 trial locations

Overseen By David Schuster, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Emory University

Disqualifiers: Inflammatory bowel disease, Systemic metastasis, 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

Compensation: Varies

Number of Visits: 7

140 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well a positron emission tomography (PET)/computed tomography (CT) scan using fluciclovine F18 compared with a PET/CT scan with 68Ga-PSMA works in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma. Fluciclovine F18 and 68Ga-PSMA are types of tracers, called radiotracers, that are injected and can accumulate in tumor cells to develop images of them during a PET/CT scan. It is not yet known whether giving fluciclovine F18 or 68Ga-PSMA may work better in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma.

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 trial coordinators or your doctor.

What data supports the effectiveness of the treatment Fluciclovine F18, Axumin, Gallium Ga68-labeled PSMA-11 for prostate cancer?

Research shows that PET imaging with tracers like 18F-fluciclovine and PSMA-targeted agents, such as Gallium Ga68-labeled PSMA-11, improves disease detection rates and influences treatment planning for prostate cancer. These tracers are effective in identifying prostate cancer and have been incorporated into clinical guidelines, with early data suggesting improved patient outcomes. ^{1 2 3 4 5}

Is the PET/CT scan with tracers for prostate cancer safe for humans?

The PET/CT scan using tracers like Fluciclovine F18 and Gallium Ga68-labeled PSMA-11 has been studied for safety, and these tracers are generally considered safe for clinical use. They have been approved by the FDA and are used in clinical settings, indicating a favorable safety profile. ^{1 2 6 7 8}

How does the PET/CT scan with tracers for prostate cancer differ from other treatments?

The PET/CT scan with tracers for prostate cancer is unique because it uses specific tracers like 68Ga-PSMA-11 and 18F-PSMA-11, which are designed to target prostate-specific membrane antigen (PSMA), making it highly sensitive and specific for detecting prostate cancer. This imaging method is particularly useful for identifying both primary tumors and metastatic lesions, offering a more precise diagnosis compared to traditional imaging techniques. ^{1 3 6 9 10}

Research Team

Ashesh Jani, MD, MSEE

Principal Investigator

Emory University

Eligibility Criteria

This trial is for men with prostate adenocarcinoma who've had surgery but still have detectable PSA levels, no signs of metastasis outside the pelvis or in bones, and can perform daily activities (ECOG 0-2). They must be willing to undergo pelvic radiotherapy and not have other recent cancers or severe illnesses like heart failure, infections needing IV antibiotics, severe lung disease, AIDS, or conditions that prevent radiation therapy.

Inclusion Criteria

I am able to get out of my bed or chair and move around.

I had surgery to remove my prostate due to adenocarcinoma.

No definitive findings for skeletal metastasis on technetium 99-m methyl diphosphonate (MDP) or F-18 PET bone scan

Exclusion Criteria

I do not have severe recent heart issues, infections needing IV antibiotics, severe lung problems, or AIDS.

I cannot have certain PET-CT scans due to my condition.

My cancer has spread to other parts of my body, confirmed by imaging or biopsy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Treatment Planning

Participants receive either fluciclovine F18 or 68Ga-PSMA intravenously and undergo PET/CT scans to plan radiation treatments

1-2 weeks

1 visit (in-person)

Radiation Treatment

Radiation treatment is administered based on PET/CT imaging results

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Every 6 months

Treatment Details

Interventions

• Fluciclovine F18
• Gallium Ga68-labeled PSMA-11

Trial Overview The study compares two types of PET/CT scans using different tracers—Fluciclovine F18 and Ga68-labeled PSMA—to see which one is better at guiding radiation treatment plans for prostate cancer. The goal is to find out if one tracer leads to improved outcomes over the other in patients post-prostatectomy.

Participant Groups

Group I: Arm I (fluciclovine F18, PET/CT) Experimental Treatment 3 Interventions

Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.

Group II: Arm II (68Ga-PSMA, PET/CT) Active Control 3 Interventions

Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Telix Pharmaceuticals (Innovations) Pty Limited

Industry Sponsor

Trials

23

Recruited

2,400+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Telix International Pty Ltd

Industry Sponsor

Trials

19

Recruited

1,300+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The PET tracer 18F-PSMA 1007 was found to be safe and well tolerated in both healthy volunteers and prostate cancer patients, with no serious adverse events reported during the study.

In terms of diagnostic effectiveness, 18F-PSMA 1007 demonstrated high accuracy in detecting prostate cancer, achieving a sensitivity of 80% and a positive predictive value of 100% in patients with untreated preoperative prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/IIa trial of 18F-prostate specific membrane antigen (PSMA) 1007 PET/CT in healthy volunteers and prostate cancer patients. Tateishi, U., Kimura, K., Tsuchiya, J., et al.[2023]

PET imaging using radiotracers like 11C-choline and 18F-fluciclovine has become crucial in evaluating prostate cancer, significantly improving disease detection rates compared to traditional imaging methods like CT and MRI.

New PSMA-targeting PET radiotracers, such as 68-Ga-PSMA-11 and 18F-DCFPyL, have been approved by the FDA, indicating their efficacy in treatment planning and potential to enhance patient outcomes in prostate cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET Imaging for Prostate Cancer. Savir-Baruch, B., Werner, RA., Rowe, SP., et al.[2021]

In a study of 24 patients with primary prostate cancer, Ga-PSMA-11 PET/CT demonstrated a high detection rate of 95.8%, confirming its effectiveness in identifying cancerous lesions.

Dynamic PET/CT imaging showed that Ga-PSMA-11 accumulation in prostate cancer lesions increased over time, suggesting its potential for enhancing treatment strategies targeting PSMA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA-11 Dynamic PET/CT Imaging in Primary Prostate Cancer. Sachpekidis, C., Kopka, K., Eder, M., et al.[2022]

Prostate-specific membrane antigen (PSMA) is a promising target for developing radiopharmaceuticals in treating aggressive prostate cancers, with ongoing clinical trials focusing on PSMA-targeted therapies, particularly using the β-particle-emitting radioisotope 177Lu.

PSMA PET imaging is crucial for evaluating tumor PSMA expression, helping to select the right patients for PSMA-targeted therapies, and studies are exploring PET parameters as predictive and prognostic biomarkers for treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of PET to Appropriately Select Patients for PSMA-Targeted Theranostics. Eshghi, A., Covington, MF., Eshghi, N., et al.[2023]

The newly developed fluorine-18 labeled PSMA ligand, [Al18F]PSMA-11, shows a high radiochemical yield of 84% and excellent purity, making it suitable for clinical applications in PET imaging of prostate cancer.

In vitro studies indicate that [Al18F]PSMA-11 has superior uptake and retention in prostate cancer cells compared to existing Gallium-68 labeled PSMA analogues, suggesting it may enhance the detection of prostate cancer in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a [Al18F]PSMA-11 preparation for clinical applications. Al-Momani, E., Israel, I., Samnick, S.[2022]

The study successfully developed six fluorine-18 labeled triazolylphenyl ureas that showed high PSMA-specific uptake in prostate cancer tumors, achieving up to 14.3% ID/g, which is more than double the uptake of the current standard, [68Ga]Ga-PSMA-HBED-CC.

These new compounds demonstrated excellent radiochemical purity and yield, making them promising candidates for clinical PET imaging of prostate cancer, with the potential for improved diagnostic capabilities over existing tracers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthesis and pre-clinical evaluation of a new class of high-affinity 18F-labeled PSMA ligands for detection of prostate cancer by PET imaging. Kelly, J., Amor-Coarasa, A., Nikolopoulou, A., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Phase I/IIa trial of 18F-prostate specific membrane antigen (PSMA) 1007 PET/CT in healthy volunteers and prostate cancer patients. [2023]

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

PET Imaging for Prostate Cancer. [2021]

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

68Ga-PSMA-11 Dynamic PET/CT Imaging in Primary Prostate Cancer. [2022]

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

Utility of PET to Appropriately Select Patients for PSMA-Targeted Theranostics. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Gross tumor volume delineation in primary prostate cancer on 18F-PSMA-1007 PET/MRI and 68Ga-PSMA-11 PET/MRI. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Validation of a [Al18F]PSMA-11 preparation for clinical applications. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Prostate Cancer-PET Imaging Update. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Synthesis and pre-clinical evaluation of a new class of high-affinity 18F-labeled PSMA ligands for detection of prostate cancer by PET imaging. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Preparation and clinical translation of 99mTc-PSMA-11 for SPECT imaging of prostate cancer. [2020]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Synthesis and Evaluation of 99mTc-Labeled PSMA-Targeted Tracers Based on the Lys-Urea-Aad Pharmacophore for Detecting Prostate Cancer with Single Photon Emission Computed Tomography. [2023]