PET/CT Scan with Tracers for Prostate Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal use of PET/CT scans for planning radiation treatments for prostate cancer. It compares two tracers, fluciclovine F18 (Axumin) and 68Ga-PSMA, which highlight cancer cells in images. The goal is to determine which tracer improves treatment outcomes for prostate cancer patients. This trial may suit those with prostate cancer who have undergone prostate surgery and have a detectable prostate-specific antigen (PSA) level. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in prostate cancer care.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study tested the safety of the tracer fluciclovine F18 in people with prostate cancer. It is generally well-tolerated, with common side effects including a temporary rise in blood pressure and minor discomfort at the injection site. Importantly, it contributes to long-term radiation exposure, which carries its own risks.

Research has shown that Gallium Ga68-labeled PSMA-11 is also safe for people with prostate cancer. Studies have found it to be well-tolerated with a low risk of serious side effects. Some individuals might experience mild symptoms like nausea or headache.

Both tracers have been used in people before and are generally considered safe. However, they involve radiation exposure, which can increase cancer risk over time. Always discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for prostate cancer because they use advanced imaging tracers that could offer more precise detection of cancerous cells. Fluciclovine F18 and Gallium Ga68-labeled PSMA-11 are unique in their ability to highlight specific cancer markers during PET/CT scans, which might help in identifying cancer spread more accurately than traditional methods. Fluciclovine F18 is particularly useful for detecting recurrent prostate cancer, while Gallium Ga68-labeled PSMA-11 targets the prostate-specific membrane antigen (PSMA), which is highly expressed in prostate cancer cells. This targeted approach could lead to better disease management by allowing for earlier and more accurate detection of prostate cancer recurrence or metastasis.

What evidence suggests that these PET/CT scan tracers could be effective for prostate cancer?

Research has shown that Fluciclovine F18 PET/CT scans, which participants in Arm I of this trial will receive, effectively detect prostate cancer, with an 81% success rate in patients. This capability aids doctors in planning treatments by accurately identifying cancer cells in the body. Studies have found it particularly useful for detecting cancer that has returned after initial treatment.

Participants in Arm II will receive Gallium Ga68-labeled PSMA-11 PET/CT, known for its high accuracy in identifying both localized and metastatic prostate cancer. It has been successfully used in real-world situations, even when PSA levels are very low. Both imaging tools effectively visualize prostate cancer, assisting doctors in planning radiation treatments and potentially improving patient outcomes. ^{6 7 8 9 10}

Who Is on the Research Team?

Ashesh Jani, MD, MSEE

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

Citations

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

18F-Fluciclovine PET/CT performance in biochemical ... 18 F-Fluciclovine PET/CT shows good performance in patients with recurrent prostate cancer leading to measurable clinical benefits.

2. axumin.com axumin.com/about/efficacy

Axumin® (fluciclovine F 18) injection | Axumin Efficacy Data Axumin demonstrated an overall (whole-body) detection rate of 81%. Of the 152 patients in the cohort: 61% (92) had positive findings within the prostate and ...

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

Update on 18F-Fluciclovine PET for Prostate Cancer Imaging The smallest short-axis diameters reported positive on 18F-fluciclovine PET/CT and CT were 0.4 cm and 0.9 cm, respectively (25). Thus, 18F- ...

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

Analysis of Prostate Cancer Imaging Agents: F-18 Fluciclovine ... This study highlights the significance of using PSMA imaging agents for PET/CT imaging of prostate cancer. Institutions should understand the ...

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

Review of 18F-Fluciclovine PET for Detection of Recurrent ... Fluorine 18 fluciclovine, a radiotracer that may be relatively new to readers, is described, and a case-based primer on the use of this agent is provided.

6. axumin.com axumin.com/about/safety-side-effects

Axumin® (fluciclovine F 18) injection | Safety & Side Effects Fluciclovine F 18 uptake is not specific for prostate cancer and may occur with other types of cancer and benign prostatic hypertrophy in primary prostate ...

7. 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 ...

8. axumin.com axumin.com/

Axumin® (fluciclovine F 18) injection | For Healthcare ... Axumin use contributes to a patient's overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling ...

9. reference.medscape.com reference.medscape.com/drug/axumin-fluciclovine-f-18-1000111

Axumin (fluciclovine F 18) dosing, indications, interactions ... Indicated for positron emission tomography (PET) in men with suspected prostate cancer recurrence based on elevated blood prostate-specific antigen (PSA) ...

10. 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- ...