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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging method called PSMA PET, which combines PET scans with either MRI or CT scans to enhance prostate cancer management. The goal is to determine if this method detects cancer spread or recurrence more effectively than standard imaging techniques. Men diagnosed with prostate cancer who are undergoing staging or restaging with unclear results from regular scans may be suitable candidates. Participants will continue with their regular treatment plans while the study monitors their progress over time. As an unphased trial, this study allows patients to contribute to the advancement of prostate cancer imaging techniques.

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 prior data suggests that PSMA PET imaging is safe for prostate cancer patients?

Research has shown that 18F-DCFPyL PET imaging is generally safe for patients. In studies, many patients experienced no major side effects. Some felt slightly unwell after the scan, but these mild effects resolved on their own. This indicates that the imaging is usually well-tolerated. Additionally, it effectively detects cancer that other standard tests might miss, aiding doctors in planning the best treatment for prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PSMA PET Scan for Prostate Cancer because it uses an advanced imaging agent called 18F-DCFPyL, combined with cutting-edge PET-MR or PET-CT technology. Unlike traditional imaging methods, this approach allows for more precise detection and localization of prostate cancer, potentially improving diagnosis and treatment planning. With PET-MR, the combination of PET and MRI data offers detailed insights into tissue structure and function, while PET-CT provides comprehensive anatomical and metabolic information, all in a single session. This could lead to earlier and more accurate detection of cancer spread, making it a promising tool in the fight against prostate cancer.

What evidence suggests that PSMA PET imaging is effective for prostate cancer management?

Research has shown that 18F-DCFPyL PET imaging, which participants in this trial will undergo, effectively diagnoses prostate cancer. Studies have demonstrated that it can detect cancer that standard imaging might miss. One study found that this imaging method accurately identified the location of cancer 84.8% to 87.0% of the time, highlighting its precision in pinpointing cancer. Another study emphasized its superior ability to correctly identify prostate cancer compared to other methods. This capability helps doctors find hidden cancer in the prostate, nearby lymph nodes, or even distant areas. Overall, these findings suggest that 18F-DCFPyL PET imaging could enhance prostate cancer management by providing clearer and more accurate information. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 have been diagnosed with prostate cancer.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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]

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 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]

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]

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]

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]

Citations

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

Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with ... Performance of 18F-DCFPyL-PET/CT achieved the study's primary endpoint, demonstrating disease localization in the setting of negative standard imaging and ...

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

Evaluation of 18F-DCFPyL PSMA PET/CT for Prostate ... In summary, the 18F-DCFPyL PET/CT method had high efficiency in diagnosing prostate cancer. CT and MRI were useful non-invasive methods for ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2020.38.15_suppl.5501

Impact of PSMA-targeted imaging with 18F-DCFPyL-PET ... The study achieved its primary endpoint: CLR of 84.8% to 87.0% among the three PyL-PET/CT readers; the LLCI for CLR by all three reviewers was > ...

4. nature.com nature.com/articles/s41598-023-35567-w

Scientific Reports 18 F]DCFPyL PET/CT is a new imaging modality to evaluate PC patients with higher sensitivity and specificity in detecting disease than other prostate specific ...

5. 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, ...

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. urotoday.com urotoday.com/conference-highlights/asco-gu-2020/asco-gu-2020-prostate-cancer/119096-psma-targeted-18f-dcfpyl-pet-ct-imaging-in-patients-with-prostate-cancer-osprey.html

PSMA-targeted 18F-DCFPyL PET/CT Imaging in Patients ... Available data suggests that PSMA targeting PET imaging may perform better in prostate cancer relative to other PET tracers such as choline and ...