PET/CT Imaging for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Psychiatric disorder, Substance abuse, Weight limit

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

Compensation: Varies

Number of Visits: 2

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial examines RefleXion Medical Radiotherapy System (RMRS) imaging to the standard of care (SOC) \[18F\]-DCFPyL positron emission tomography-computed tomography (PET-CT) imaging in patients with prostate cancer. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of a tracer, \[18F\]-DCFPyL, that binds to prostate specific membrane antigen (PSMA) on tumor cells. These PSMA tumor cells can then be identified on PET imaging. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. The RMRS is a imaging-therapy combination system that can plan for and deliver radiation therapy as well perform \[18F\]-DCFPyL PET-CT imaging. Comparing the imaging from the standard of care \[18F\]-DCFPyL-PET-CT with the \[18F\]-DCFPyL imaging from RMRS may help improve the quality of the imaging captured and determine if imaging can be done on the RMRS at the same time as planning for radiation therapy, which would reduce the number of scans needed to plan for radiation for prostate cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of PET/CT imaging for prostate cancer treatment?

PET/CT imaging is becoming more important in diagnosing and managing prostate cancer, especially for detecting cancer spread and recurrence. It helps overcome limitations of traditional imaging methods, making it a valuable tool in treatment planning and follow-up. ^{1 2 3 4 5}

Is PET/CT imaging safe for humans?

The research does not provide specific safety data for PET/CT imaging, but it is widely used in prostate cancer diagnosis, suggesting it is generally considered safe in clinical settings. ^{3 6 7 8 9}

How is PET/CT imaging unique for prostate cancer treatment?

PET/CT imaging is unique for prostate cancer because it uses advanced imaging technology to detect cancer more accurately by highlighting specific biological markers in the body. This approach allows for a more tailored treatment plan, as it provides detailed insights into the tumor's characteristics and spread, which is not possible with traditional imaging methods. ^{3 6 9 10 11}

Research Team

Jeffrey Wong

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for adults over 21 with prostate cancer who are scheduled to undergo standard PET-CT imaging using a tracer that targets tumor cells. It's not suitable for individuals exceeding 450 pounds or those with psychiatric/substance abuse issues that could affect study participation.

Inclusion Criteria

Documented informed consent of the participant and/or legally authorized representative

I am scheduled for a specific PET-CT scan before joining the study.

I am scheduled for a specific PET-CT scan with [18F]-DCFPyL.

Exclusion Criteria

Known psychiatric or substance abuse disorder that would interfere with conduct of the study

I weigh less than or equal to 450 pounds.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Participants receive [18F]-DCFPyL intravenously and undergo [18F]-DCFPyL PET-CT over 30 minutes per standard of care. Patients with PET avid lesions then undergo a X1 RMRS PET-CT imaging-only session within 120 minutes of injection over 20-35 minutes.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

Up to 72 hours

1 visit (in-person or virtual)

Treatment Details

Interventions

• Computed Tomography
• Positron Emission Tomography

Trial Overview The study compares the performance of RefleXion Medical Radiotherapy System (RMRS) imaging against standard PET-CT in detecting prostate cancer. The goal is to see if RMRS can improve image quality and combine scan planning with radiation therapy, potentially reducing the number of scans needed.

Participant Groups

Group I: Diagnostic ([18F]-DCFPyL PET-CT, X1 RMRS PET-CT) Experimental Treatment 3 Interventions

Patients receive \[18F\]-DCFPyL IV and undergo \[18F\]-DCFPyL PET-CT over 30 minutes per SOC. Patients with PET avid lesions then undergo a X1 RMRS PET-CT imaging-only session within 120 minutes of injection over 20-35 minutes.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Choline PET/CT is an effective noninvasive tool for restaging prostate cancer patients with rising prostate-specific antigen levels after treatment, but it is not recommended for initial diagnosis or staging due to limitations in assessing intraprostatic tumors and small lymph node involvement.

While choline PET/CT is well-established, further research is needed to clarify the clinical roles of PET/CT using acetate and fluoride tracers in prostate cancer imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of PET/computed tomography scan in the management of prostate cancer. Picchio, M., Giovannini, E., Messa, C.[2015]

Prostate cancer is the most common type of cancer affecting the urinary system in men, and its biological diversity makes diagnosis and treatment challenging.

Positron emission tomography/computed tomography (PET/CT) is highlighted as a valuable noninvasive imaging tool that can enhance the diagnosis and understanding of prostate cancer biology, with various new radiopharmaceuticals being developed for this purpose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Positron emission tomography for molecular imaging of prostate cancer]. Shen, GH., Zhang, WJ., Jia, ZY., et al.[2018]

References

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

Imaging prostate cancer: a multidisciplinary perspective. [2022]

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

Fluorodeoxyglucose positron emission tomography as an outcome measure for castrate metastatic prostate cancer treated with antimicrotubule chemotherapy. [2018]

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

Rapidly changing landscape of PET/CT imaging in prostate cancer. [2022]

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

The role of PET/computed tomography scan in the management of prostate cancer. [2015]

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

The Role of PET-CT Imaging in Prostate Cancer. [2021]

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

The use of PET/CT in prostate cancer. [2018]

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

PET/CT in Prostate Cancer. [2023]

8. China pubmed.ncbi.nlm.nih.gov

Systematic review & meta-analysis of positron emission tomography/computed tomography and bone scan in the diagnosis of prostate lesions. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The role of 11C-choline and 18F-fluorocholine positron emission tomography (PET) and PET/CT in prostate cancer: a systematic review and meta-analysis. [2022]

10. China pubmed.ncbi.nlm.nih.gov

[Positron emission tomography for molecular imaging of prostate cancer]. [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

[PET-CT and PET-MRI of the prostate : From 18F-FDG to 68Ga-PSMA]. [2022]