PSMA PET Scan for Prostate Cancer

(PM-PPR Trial)

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Inability to lie still, Metastatic disease, MRI contraindication, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the Princess Margaret Cancer Centre PSMA registry is to assess the contribution of 18F-DCFPyL (PSMA) PET imaging (PET/MR or PET/CT) to the management of patients with prostate cancer (PCa). Background: Currently, patients with intermediate or high risk prostate cancer are staged with CT abdomen and pelvis and bone scan to assess for distant metastases. Patients with biochemical recurrence after primary therapy are restaged in a similar manner. Locally, multiparametric MR of the prostate or prostate bed may also be obtained in select cases. Patients recruited for this registry will be staged/ restaged with PSMA PET (PET/CT or PET/MR) to determine whether this imaging strategy results in more accurate detection of metastatic disease (for patients undergoing primary staging) or detection of local recurrence or distant disease (for patients undergoing restaging). Choice of imaging method (PET/CT or PET/MR) will be made by one of the study PIs, based on clinical judgement taking into account the specific exam indication, prior recent imaging, and suitability for MR imaging. Study design: This is a single arm study to assess the contribution of PSMA PET imaging (PET/MR or PET/CT) to the management of patients with prostate cancer (PCa). In this prospective trial, the investigators will recruit 200 men whom will undergo PET imaging using an integrated PET/CT scanner or with an integrated PET/MR. Patients will receive standard treatment for PCa according to UHN/PMH urology oncology site policies. Treatment outcome including clinical response, blood work including serial serum PSA, and follow-up imaging if performed up to 5 years will be recorded.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It seems that participants will continue with their standard treatment for prostate cancer.

What data supports the effectiveness of the treatment 18F-DCFPyL PET/CT for prostate cancer?

Research shows that 18F-DCFPyL PET/CT is better than traditional imaging methods at finding prostate cancer that has spread, helping doctors make better treatment decisions. It accurately detects cancer in lymph nodes and bones, and can guide targeted biopsies, making it a valuable tool for managing prostate cancer. ^{1 2 3 4 5}

Is the PSMA PET Scan using 18F-DCFPyL safe for humans?

The PSMA PET Scan using 18F-DCFPyL has been tested in multiple major trials and is approved by the U.S. Food and Drug Administration, indicating it is generally considered safe for use in humans. ^{3 6 7 8 9}

How is the PSMA PET scan treatment for prostate cancer different from other treatments?

The PSMA PET scan treatment uses a special imaging agent called 18F-DCFPyL, which targets a protein highly expressed in prostate cancer cells, allowing for precise imaging and diagnosis. This approach is unique because it provides high accuracy in locating cancer within the body, which can guide targeted biopsies and treatment decisions. ^{3 4 5 10 11}

Eligibility Criteria

Men over 18 with prostate cancer, either being initially staged for high-risk or unfavorable intermediate-risk disease, or restaged due to unclear results from standard tests. Eligible men must have a histologic diagnosis and be fit for PET scans. Men with clear-cut metastatic disease not benefiting from PET findings are excluded.

Inclusion Criteria

Being staged or restaged for any of the following indications:

My prostate cancer is high risk or unfavorable intermediate-risk.

I am 18 years old or older.

Exclusion Criteria

Contraindication to MRI for patients undergoing PET/MR only as per Joint Department of Medical Imaging policies

My cancer has clearly spread, and a PET scan won't change my treatment plan.

I cannot stay still for PET scans.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo PSMA PET imaging using PET/CT or PET/MR to assess the detection of lymph node and distant metastases

1-2 weeks

1 visit (in-person)

Standard Treatment

Participants receive standard treatment for prostate cancer according to UHN/PMH urology oncology site policies

Varies based on individual treatment plans

Follow-up

Participants are monitored for clinical response, blood work including serial serum PSA, and follow-up imaging if performed

Up to 5 years

Treatment Details

Interventions

• 18F-DCFPyL

Trial Overview The trial is evaluating the effectiveness of PSMA PET imaging (using PET/MR or PET/CT) in improving the staging and restaging process for prostate cancer management. It's a single-arm study involving 200 men who will receive this imaging alongside standard treatments.

Participant Groups

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

Will use a newer technology called PET-MR that combines a Positron Emission Tomography (PET) scan with Magnetic Resonance Imaging (MRI) scan. This new combined imaging test, where PET and MRI data is gathered at one time, will be performed on an integrated PET-MR scanner located at Toronto General Hospital. Or technology called PET-CT that combines a Positron Emission Tomography (PET) scan with a computed tomography (CT) scan. This combined imaging test, where PET and CT data is gathered at one time, will be performed on an integrated PET-CT scanner located at Princess Margaret Cancer Centre. Choice of imaging method (PET/CT or PET/MR) will be made by one of the study PIs, based on clinical judgement taking into account the specific exam indication, prior recent imaging, and suitability for MR imaging.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

In a study of 93 patients with biochemically recurrent prostate cancer, 18F-DCFPyL PET/CT scans identified disease in 82% of cases, significantly outperforming conventional imaging, which had an accuracy below 20%.

The use of 18F-DCFPyL PET/CT led to a change in management for 44% of patients, often shifting treatment from androgen deprivation therapy to targeted radiotherapy, highlighting its potential to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance of 18F-DCFPyL positron emission tomography/computed tomography for biochemically recurrent prostate cancer and change-of-management analysis. Chaussé, G., Ben-Ezra, N., Stoopler, M., et al.[2021]

The novel PSMA-targeted PET radiotracer [(18)F]DCFPyL detected 139 sites of metastatic prostate cancer in patients, significantly outperforming conventional imaging modalities (CIM), which only identified 45 lesions.

This study suggests that [(18)F]DCFPyL PET imaging is more effective in identifying metastatic disease, especially in cases where CIM results were negative or equivocal, highlighting its potential as a superior diagnostic tool for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PSMA-Based [(18)F]DCFPyL PET/CT Is Superior to Conventional Imaging for Lesion Detection in Patients with Metastatic Prostate Cancer. Rowe, SP., Macura, KJ., Mena, E., et al.[2022]

The study evaluated the dosimetry of the PET radiotracer 18F-DCFPyL in nine patients with metastatic prostate cancer, revealing that the lacrimal glands received the highest absorbed dose, which is important for understanding potential side effects during imaging and therapy.

Using advanced Monte-Carlo models, the research provided new insights into the dose received by the lacrimal and salivary glands, which are critical for assessing the safety and efficacy of 18F-DCFPyL in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined model-based and patient-specific dosimetry for 18F-DCFPyL, a PSMA-targeted PET agent. Plyku, D., Mena, E., Rowe, SP., et al.[2018]

The study demonstrated that the 18F-DCFPyL PET imaging can effectively distinguish malignant prostate cancer from benign tissue, with significant differences in uptake values observed as early as 5 minutes post-injection in 10 patients with high-risk prostate cancer.

The pharmacokinetic analysis revealed that malignant prostate tissue had a 15-fold higher influx value (Ki) compared to benign prostatic hyperplasia and normal prostate tissue, indicating that 18F-DCFPyL PET imaging can be a valuable tool for early detection of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of Dynamic 18F-DCFPyL PET/CT Imaging of Prostate Adenocarcinoma in High-Risk Primary Prostate Cancer Patients. Lu, M., Lindenberg, L., Mena, E., et al.[2023]

In a study of 30 patients with intermediate to high-risk primary prostate cancer, 18F-DCFPyL-PET/CT demonstrated a high accuracy in localizing clinically significant prostate cancer (csPCa), with a detection rate of 93% for recommended biopsy segments.

The diagnostic performance of 18F-DCFPyL-PET/CT showed a sensitivity of 61.4% and specificity of 88.3% for identifying csPCa, indicating its potential as a valuable tool for guiding targeted prostate biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of prostate cancer with 18F-DCFPyL PET/CT compared to final histopathology of radical prostatectomy specimens: is PSMA-targeted biopsy feasible? The DeTeCT trial. Bodar, YJL., Jansen, BHE., van der Voorn, JP., et al.[2021]

The synthesized imaging agent [(18)F]DCFPyL effectively targets the prostate-specific membrane antigen (PSMA), showing a strong binding affinity (K(i) value of 1.1 nmol/L) and high uptake in PSMA-positive prostate tumors in mouse models.

[(18)F]DCFPyL demonstrated significant tumor delineation in PET imaging, with a remarkable uptake ratio of 358:1 between PSMA-positive and PSMA-negative tumors, indicating its potential as a specific imaging tool for prostate cancer with minimal uptake in non-target tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2-(3-{1-Carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid, [18F]DCFPyL, a PSMA-based PET imaging agent for prostate cancer. Chen, Y., Pullambhatla, M., Foss, CA., et al.[2021]

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]

The 18F-labeled PSMA-directed PET agent [18F]DCFPyL (PYLARIFY) has shown significant clinical utility in staging and restaging prostate cancer, supported by major trials like OSPREY and CONDOR.

Following its recent FDA approval, [18F]DCFPyL is expected to see increased adoption for imaging and management of prostate cancer, enhancing image-guided treatment strategies in both the U.S. and Europe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[18F]DCFPyL PET/CT for Imaging of Prostate Cancer. Rowe, SP., Buck, A., Bundschuh, RA., et al.[2022]

In a study involving 10 patients with newly diagnosed prostate cancer, the novel PET tracer 18F-PSMA-7Q demonstrated comparable imaging characteristics to the FDA-approved tracer 18F-DCFPyL, with both detecting 17 lesions without significant differences in uptake values.

18F-PSMA-7Q showed limited urinary excretion, which may provide an advantage for detecting pelvic lesions, suggesting it could be a promising alternative for prostate cancer imaging pending further validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective intraindividual comparison of 18F-PSMA-7Q and 18F-DCFPyL PET/CT in patients with newly diagnosed prostate cancer. Liu, Y., Zhang, X., Liu, J., et al.[2023]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Diagnostic performance of 18F-DCFPyL positron emission tomography/computed tomography for biochemically recurrent prostate cancer and change-of-management analysis. [2021]

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

PSMA-Based [(18)F]DCFPyL PET/CT Is Superior to Conventional Imaging for Lesion Detection in Patients with Metastatic Prostate Cancer. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Combined model-based and patient-specific dosimetry for 18F-DCFPyL, a PSMA-targeted PET agent. [2018]

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

A Pilot Study of Dynamic 18F-DCFPyL PET/CT Imaging of Prostate Adenocarcinoma in High-Risk Primary Prostate Cancer Patients. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Detection of prostate cancer with 18F-DCFPyL PET/CT compared to final histopathology of radical prostatectomy specimens: is PSMA-targeted biopsy feasible? The DeTeCT trial. [2021]

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

2-(3-{1-Carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid, [18F]DCFPyL, a PSMA-based PET imaging agent for prostate cancer. [2021]

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

18F-Labeled Radiotracers for Prostate-specific Membrane Antigen: Historical Perspective and Future Directions. [2022]

8. 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]

9. Germany pubmed.ncbi.nlm.nih.gov

[18F]DCFPyL PET/CT for Imaging of Prostate Cancer. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Prospective intraindividual comparison of 18F-PSMA-7Q and 18F-DCFPyL PET/CT in patients with newly diagnosed prostate cancer. [2023]

11. Greece pubmed.ncbi.nlm.nih.gov

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