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

1500 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a multi-center, single-arm, open-label, phase III trial in patients with biopsy-proven prostate cancer. Patients will receive regular standard of clinical care. The only study-specific procedures will the administration of 18F-DCFPyL followed by a PET/CT scan. Differences in theoretical optimal clinical management based on a review of clinical, biochemical and radiographic subject data before and after 18F-DCFPyL PET/CT imaging by a central panel of experts will be captured at study completion.

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 data supports the effectiveness of the treatment 18F-DCFPyL PET/CT Imaging for Prostate Cancer?

Research shows that 18F-DCFPyL PET/CT is effective in detecting recurrent prostate cancer, with detection rates improving as PSA (a protein produced by the prostate) levels increase. It also led to changes in treatment plans for most patients, helping doctors make better decisions about managing the disease. ^{1 2 3 4 5}

Is 18F-DCFPyL PET/CT imaging safe for humans?

Yes, 18F-DCFPyL PET/CT imaging is generally safe for humans. In a study, 22 subjects reported mild side effects after the scan, but all of these resolved completely. ^{1 2 3 6 7}

How does 18F-DCFPyL PET/CT imaging differ from other prostate cancer treatments?

18F-DCFPyL PET/CT imaging is unique because it uses a special radiotracer that targets the prostate-specific membrane antigen (PSMA), allowing for more precise detection of prostate cancer recurrence compared to conventional imaging methods. This can lead to significant changes in patient management and treatment plans. ^{2 3 5 6 7}

Eligibility Criteria

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 am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[18F]DCFPyL PET/CT versus [18F]fluoromethylcholine PET/CT in Biochemical Recurrence of Prostate Cancer (PYTHON): a prospective, open label, cross-over, comparative study. [2023]

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

A Prospective Study on 18F-DCFPyL PSMA PET/CT Imaging in Biochemical Recurrence of Prostate Cancer. [2020]

3. Switzerland 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. [2021]

4. Germany 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. [2021]

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

Diagnostic Performance of PSMA-Based 18 F-DCFPyL PET/CT in Prostate Cancer Patients After Definitive Treatment With PSA Level ≤0.2 ng/mL. [2023]

6. Greece pubmed.ncbi.nlm.nih.gov

Role of 18F-DCFPyL PET/CT in patients with suspected prostate cancer. [2022]

7. United States 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. [2020]