18F-DCFPyL PET/CT Imaging for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 2 & 3

Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Disqualifiers: Medically unstable, Weight limit, Claustrophobia

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: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging method called 18F-DCFPyL PET/CT to improve prostate cancer management. The goal is to determine if this technique can help doctors make better treatment decisions by providing clearer images of the cancer. The trial is open to men already diagnosed with prostate cancer, particularly those considered high-risk or who have experienced a recurrence after treatment. Participants should be able to lie still for about 40 minutes for the scan and handle an injection. As a Phase 2, Phase 3 trial, this research measures the imaging method's effectiveness in an initial, smaller group and is in the final step before FDA approval. It offers participants a chance to contribute to a potentially groundbreaking advancement in prostate cancer management.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that 18F-DCFPyL PET/CT imaging is safe for prostate cancer patients?

Research has shown that 18F-DCFPyL PET/CT safely detects prostate cancer. Studies have found that this method can successfully identify cancer that other tests might miss. In one study, 22 participants experienced mild side effects after their scans, but all issues resolved completely. This indicates that patients generally tolerate the procedure well.

Overall, the studies provide strong evidence that 18F-DCFPyL PET/CT is both effective and safe for patients. For those considering joining a trial, this imaging method has a proven safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 18F-DCFPyL PET/CT scan for prostate cancer because it offers a new way to see the disease. Unlike standard imaging techniques like bone scans and CT scans, this method uses a special radioactive tracer, 18F-DCFPyL, that targets a protein prevalent in prostate cancer cells, called PSMA. This allows for more precise detection of cancer spread, potentially catching it earlier and more accurately. This precision could lead to better treatment decisions and outcomes for patients.

What evidence suggests that 18F-DCFPyL PET/CT is effective for prostate cancer?

Studies have shown that 18F-DCFPyL PET/CT, the imaging method used in this trial, effectively diagnoses prostate cancer. This method can detect prostate cancer that might not appear on regular scans and performs well even when PSA levels, proteins made by prostate cells, are very low. Research indicates that using 18F-DCFPyL PET/CT can alter treatment plans for prostate cancer in about 43.5% of patients. Overall, it serves as a powerful tool for more accurate identification and management of prostate cancer. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Men over 18 with prostate cancer and signs of advanced disease, like bone pain or high PSA levels. They must be able to lie still for a PET/CT scan and fit within the machine's size limits. Those with severe claustrophobia, unstable health conditions, or who exceed the weight or size capacity for the PET/CT equipment cannot participate.

Inclusion Criteria

I am male.

I am at high risk for prostate cancer based on my Gleason score, PSA levels, T stage, or symptoms.

I can lie still for 40 minutes and handle an IV injection for a PET/CT scan.

Exclusion Criteria

Patients with unmanageable claustrophobia

I am not currently experiencing any severe health crises like heart or breathing problems.

I weigh less than 400 lbs and can fit into a PET/CT scanner.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Administration of 18F-DCFPyL followed by a PET/CT scan

1 day

1 visit (in-person)

Immediate Observation

Monitoring for adverse events up to 90 minutes post-administration of 18F-DCFPyL

2 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• 18F-DCFPyL PET/CT

Trial Overview The trial is testing how well an imaging drug called 18F-DCFPyL works in detecting prostate cancer spread when used during a PET/CT scan. The goal is to see if this method changes doctors' decisions about patient care compared to standard methods.

How Is the Trial Designed?

Group I: 18F-DCFPyL PET/CT Experimental Treatment 1 Intervention

18F-DCFPyL PET/CT Scan

Who Is Running the Clinical Trial?

Sir Mortimer B. Davis - Jewish General Hospital

Lead Sponsor

Trials

61

Recruited

25,800+

Published Research Related to This Trial

In a study of 72 men with biochemical recurrence of prostate cancer, 18F-DCFPyL PET/CT demonstrated a high positivity rate of 85%, which increased with higher prostate-specific antigen (PSA) levels, indicating its efficacy in detecting prostate cancer lesions.

18F-DCFPyL PET/CT identified more lesions than conventional imaging methods, leading to treatment changes in 60% of patients, highlighting its potential to significantly impact clinical management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Evaluation of 18F-DCFPyL PET/CT in Biochemically Recurrent Prostate Cancer in an Academic Center: A Focus on Disease Localization and Changes in Management. Song, H., Harrison, C., Duan, H., et al.[2020]

In a study of 47 men with recurrent prostate cancer, 18F-DCFPyL PET imaging was positive in over 91% of cases, effectively identifying local and metastatic recurrences that were not detected by other imaging methods.

For patients with limited recurrence, PET-directed local ablative therapies led to a favorable PSA response in 76.9% of cases, with nearly 25% achieving a complete biochemical response, highlighting the efficacy of this targeted approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-DCFPyL (PSMA) PET in the Management of Men with Biochemical Failure after Primary Therapy: Initial Clinical Experience of an Academic Cancer Center. Metser, U., Ortega, C., Hussey, D., et al.[2021]

In a study of 130 subjects with biochemical recurrence of prostate cancer, 18F-DCFPyL PET/CT imaging successfully localized recurrent cancer in up to 92% of cases with higher PSA levels, demonstrating its sensitivity as a diagnostic tool.

The use of 18F-DCFPyL PET/CT significantly impacted patient management, with 87.3% of subjects experiencing changes in their treatment plans, indicating its effectiveness in guiding oncologists' decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective Study on 18F-DCFPyL PSMA PET/CT Imaging in Biochemical Recurrence of Prostate Cancer. Rousseau, E., Wilson, D., Lacroix-Poisson, F., et al.[2020]

In a study of 253 patients with biochemically recurrent hormone-sensitive prostate cancer, 40.7% had a change in treatment management after undergoing 18F-DCFPyL PET/CT imaging, highlighting its significant impact on clinical decision-making.

Positive findings from the 18F-DCFPyL PET/CT scan and positive pathological lymph node status were strong predictors for changing treatment plans, while a positive surgical margin was associated with a lower likelihood of management change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management impact of 18F-DCFPyL PET/CT in hormone-sensitive prostate cancer patients with biochemical recurrence after definitive treatment: a multicenter retrospective study. Meijer, D., van Leeuwen, PJ., Oosterholt, PMJ., et al.[2021]

In a study of 56 patients with suspected prostate cancer, the novel radiotracer 18F-DCFPyL demonstrated high sensitivity (90%) and specificity (100%) for detecting prostate cancer, making it a reliable diagnostic tool.

The imaging results showed a strong correlation between the radiotracer uptake (measured by SUVmax and SULmax) and serum PSA levels, indicating that 18F-DCFPyL PET/CT is effective for initial diagnosis and lymph node staging in suspected prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of 18F-DCFPyL PET/CT in patients with suspected prostate cancer. Zhang, T., Yang, S., Lin, L., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8382991/

Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with ... This study was designed to evaluate the performance of 18F-DCFPyL-PET/CT in prostate cancer patients with BCR and non-informative standard-of-care imaging.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10030046/

The diagnostic performance of 18F-DCFPyL PET in ... 18 F-DCFPyL PSMA PET has a strong predictive value for primary prostate cancer and is an effective method for the non-invasive diagnosis of prostate cancer.

3. jnm.snmjournals.org jnm.snmjournals.org/content/early/2025/06/05/jnumed.124.269266/tab-figures-data

Imaging Efficacy of [ 18 F]CTT1057 PET/CT in Patients with ... A Phase 3 study of 18F-DCFPyL-PET/CT in Patients with Biochemically Recurrent Prostate Cancer (CONDOR): An Analysis of Disease Detection Rate ...

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1355236/full

Effect of 18 F-DCFPyL PET on changes in management ... The pooled proportion of prostate cancer patients experienced management changes was 43.5%, and 18F-DCFPyL PET has a significant impact on treatment options.

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.344

Early detection of recurrent prostate cancer using 18F ... 18F-DCFPyL PET/CT demonstrates high detection rate for recurrent prostate cancer even in patients with minimally detectable PSA levels.

6. 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 ...

7. jnm.snmjournals.org jnm.snmjournals.org/content/60/11/1587

A Prospective Study on 18 F-DCFPyL PSMA PET/CT Imaging ... Twenty-two subjects reported mild adverse events after the scan; all resolved completely. Conclusion: 18F-DCFPyL PET/CT is safe and sensitive ...

8. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2020.597422/full

Evaluation of 18F-DCFPyL PSMA PET/CT for Prostate ... Conclusion: 18F-DCFPyL PSMA PET/CT had good sensitivity and specificity for the diagnosis of prostate cancer. The DR of 18F-DCFPyL PSMA PET/CT ...

9. mdpi.com mdpi.com/2072-6694/17/8/1272

Diagnostic Capability and Improved Clinical Management ... The study demonstrated the ability of 18F-DCFPyL PET/CT to detect previously unsuspected disease in the prostate bed, lymph nodes, and distant metastases, ...