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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for imaging prostate cancer using the RefleXion Medical Radiotherapy System (RMRS) and compares it to standard PET-CT imaging. PET-CT uses a small amount of radioactive material to detect cancer cells, while RMRS aims to both identify cancer cells and plan radiation treatment simultaneously. The trial seeks to determine if RMRS can provide better images and reduce the number of necessary scans. Men already scheduled for a standard PET-CT scan for prostate cancer may be suitable candidates for this trial. As an unphased trial, it offers patients the chance to contribute to innovative imaging research that could enhance future 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.

What prior data suggests that the RefleXion Medical Radiotherapy System is safe for imaging prostate cancer?

Research has shown that [18F]-DCFPyL PET-CT imaging is generally safe for patients. Studies have found that this method is well-tolerated, with only minor side effects reported. In one study, most patients did not experience any serious negative effects from the imaging process. This technique uses a tiny amount of radioactive material that attaches to prostate cancer cells, helping doctors see the cancer clearly.

Additionally, researchers are testing the RefleXion Medical Radiotherapy System (RMRS) to determine if it can improve the imaging process. The goal is to combine imaging and radiation therapy planning in one step, potentially reducing the number of scans patients need. While RMRS remains under study, the focus is on ensuring safety and enhancing the patient experience.

Overall, evidence supports the safety of [18F]-DCFPyL PET-CT, and efforts like RMRS aim to make the process more efficient without compromising safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

PET/CT imaging for prostate cancer is unique because it combines advanced imaging techniques to provide a more precise picture of the cancer's location and activity. Unlike traditional imaging methods like standard CT or MRIs, this approach uses a radioactive tracer, [18F]-DCFPyL, which specifically targets prostate cancer cells, making them more visible on the scan. Researchers are excited about this method because it can detect cancer spread with greater accuracy, potentially leading to more tailored treatment plans for patients. This imaging technique could significantly enhance how doctors identify and monitor prostate cancer, offering a promising step forward in patient care.

What evidence suggests that the RefleXion Medical Radiotherapy System is effective for prostate cancer imaging?

Research has shown that \[18F\]-DCFPyL PET-CT imaging, which participants in this trial will undergo, effectively detects prostate cancer. Studies have found that it identifies at least one cancerous area in 59% to 66% of patients. One study demonstrated an 80% sensitivity rate, meaning it correctly identifies 80% of actual cancer cases. It also has a high specificity rate of 87%, correctly identifying 87% of cases without cancer. In another study, this imaging technique revealed increased activity in the prostate in 97.8% of patients, highlighting its effectiveness in assessing prostate cancer. Overall, this method reliably spots prostate cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Jeffrey Wong

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. jnm.snmjournals.org jnm.snmjournals.org/content/58/11/1797

18F-DCFPyL PET/CT in the Detection of Prostate Cancer ... Our data demonstrated a higher detection rate of lesions characteristic of prostate cancer on images acquired at 120 min after injection than 60 ...

2. advancesradonc.org advancesradonc.org/article/S2452-1094(23)00070-2/fulltext

Using 18F-DCFPyL Prostate-Specific Membrane Antigen ... In this work, we investigated using both PSMA PET and mpMRI in planning focal intraprostatic boosts using stereotactic body radiation therapy (SBRT).

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33622706/

Diagnostic Performance of 18 F-DCFPyL-PET/CT in ... - PubMed The disease detection rate was 59% to 66% (at least one lesion detected per patient by 18F-DCFPyL-PET/CT by central readers). Conclusions: ...

4. auajournals.org auajournals.org/doi/10.1097/JU.0000000000004659

DCFPyL Prostate-Specific Membrane Antigen Positron ... Our findings indicate that [18F]-DCFPyL PSMA PET/CT demonstrates solid diagnostic performance in intermediate-risk PCa with 80% sensitivity, 87% ...

5. ejhi.springeropen.com ejhi.springeropen.com/articles/10.1186/s41824-018-0044-0

18 F-DCFPyL PET/CT in primary staging of prostate cancer F-DCFPyL PET/CT showed increased uptake in the prostate in 131 patients (97.8%). One patient without increased 18F-DCFPyL uptake in the prostate ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5261857/

PSMA-Based [18F]DCFPyL PET/CT Is Superior to ... Our group has previously published data on detecting primary and metastatic prostate cancer using a first-in-class radiofluorinated small molecule inhibitor of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4531836/

Initial Evaluation of [18F]DCFPyL for Prostate-Specific ... Here we present initial safety, biodistribution, and radiation dosimetry results with [18F]DCFPyL, a second-generation fluorine-18-labeled small-molecule PSMA ...

8. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251575

Comparison of [¹⁸F]PSMA-1007, [¹⁸F]DCFPyL, and [⁶⁸Ga ... Comparison of [¹⁸F]PSMA-1007, [¹⁸F]DCFPyL, and [⁶⁸Ga]Ga-PSMA-11 in PET/CT Imaging for Prostate Cancer: A Systematic Review and Meta-Analysis.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03739684

NCT03739684 | Study of 18F-DCFPyL PET/CT Imaging in ... This study evaluates the diagnostic performance and safety of 18F-DCFPyL (PyL) PET/CT imaging in patients with suspected recurrence of prostate cancer who ...

10. advancesradonc.org advancesradonc.org/article/S2452-1094(25)00189-7/fulltext

DCFPyL PSMA Imaging on the RefleXion X1 PET-CT ... Data from this study would allow assessment of the technical performance of the PET imaging subsystem in patients with prostate cancer ...