PSMA-PET Scan for Recurrent Prostate Cancer

(PREP Trial)

Recruiting at 5 trial locations

Overseen By Catherine Hildebrand, PhD, Project Coordinator

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Disqualifiers: Sarcomatoid, Spindle cell, Neuroendocrine, 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: Unknown

3070 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to institute a province-wide registry leveraging the availability of a new Positron Emission Tomography tracer, \[18F\]-DCFPyL and PET expertise across Ontario centers to improve our ability to characterize patterns of recurrence and personalize therapies in men with recurrent prostate cancer after primary treatment.

Will I have to stop taking my current medications?

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

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

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

What data supports the effectiveness of the drug Piflufolastat F 18 (18F-DCFPyL) for imaging recurrent prostate cancer?

Research shows that Piflufolastat F 18 (18F-DCFPyL) is effective for imaging prostate cancer because it targets a protein commonly found in these cancer cells, helping doctors better see where the cancer is in the body. It has been approved by the FDA for use in patients with suspected cancer spread or recurrence, and studies like OSPREY and CONDOR have shown its usefulness in guiding treatment decisions. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Piflufolastat F 18 (18F-DCFPyL) for imaging recurrent prostate cancer?

Research shows that Piflufolastat F 18 is effective for imaging prostate cancer because it targets a specific protein found in most prostate cancers, helping doctors see the cancer more clearly. It has been tested in major trials like OSPREY and CONDOR, which showed its usefulness in staging and managing prostate cancer. ^{1 2 3 4 5}

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

Piflufolastat F 18, also known as 18F-DCFPyL, has been approved by the U.S. Food and Drug Administration for use in imaging prostate cancer, indicating it has been evaluated for safety. It has been tested in major trials like OSPREY and CONDOR, which are part of the approval process, suggesting it is generally considered safe for human use in the context of prostate cancer imaging. ^{1 2 3 4 5}

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

Piflufolastat F 18, also known as 18F-DCFPyL, has been approved by the U.S. Food and Drug Administration for use in imaging prostate cancer, indicating it has been evaluated for safety in humans. It has been tested in major trials like OSPREY and CONDOR, which are part of the approval process, suggesting it is generally considered safe for its intended diagnostic use. ^{1 2 3 4 5}

How does the PSMA-PET scan treatment for recurrent prostate cancer differ from other treatments?

The PSMA-PET scan using piflufolastat F-18 is unique because it targets prostate-specific membrane antigen (PSMA) for more accurate imaging, which helps in better staging and management of prostate cancer compared to conventional imaging methods. This approach is particularly useful for detecting recurrent prostate cancer and guiding treatment decisions. ^{1 2 3 4 6}

How does the PSMA-PET scan treatment for recurrent prostate cancer differ from other treatments?

The PSMA-PET scan using piflufolastat F-18 is unique because it targets the prostate-specific membrane antigen (PSMA) for more accurate imaging of prostate cancer, which helps in better staging and management decisions compared to conventional imaging methods that have limited sensitivity for detecting metastatic disease. ^{1 2 3 4 6}

Research Team

Glenn Bauman, MD, FRCPC

Principal Investigator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Ur Metser, MD, FRCPC

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

Men over 18 who've had primary treatment for prostate cancer and suspect it's come back. They must have a rising PSA level after surgery or radiotherapy, be able to lie still for an hour, and not have had a PSMA PET scan in the last 6 months. Those with certain aggressive cancer types or who don't fit specific study groups without approval are excluded.

Inclusion Criteria

I had surgery for prostate cancer and still have signs of the disease.

I had surgery or radiation for prostate cancer aimed at curing it.

I am a man aged 18 or older.

Exclusion Criteria

Prior PSMA PET scan within 6 months of enrollment.

I cannot stay still for 60 minutes for a scan.

Patients falling outside of Cohorts 1-6 where independent adjudication by CCO does not support participation in the Registry.

Treatment Details

Interventions

• [18F]-DCFPyL PET/ CT scan

Trial Overview The trial is testing a new type of PET scan using [18F]-DCFPyL to detect recurrent prostate cancer across Ontario. It aims to personalize therapy by better understanding how the cancer comes back after initial treatment.

Participant Groups

Group I: Cohort 7 Experimental Treatment 1 Intervention

\[18F\]-DCFPyL as a problem-solving tool in patients with prostate cancer when confirmation of the site of disease and/or disease extent may impact clinical management. Patients in this cohort require approval from an independent adjudication by Cancer Care Ontario.

Group II: Cohort 6 Experimental Treatment 1 Intervention

Men with biochemical failure after primary radiation therapy (external beam, brachytherapy or combinations together with or without hormone therapy) will be restaged with \[18F\]-DCFPyL PET/ CT scan (PSMA PET)

Group III: Cohort 5 Experimental Treatment 1 Intervention

Men who have prior PSMA directed treatment for oligometastatic disease, such as lesion directed therapy (e.g. stereotactic radiosurgery) or systemic therapy (e.g. hormone therapy or chemotherapy) with subsequent biochemical failure will be restaged with \[18F\]-DCFPyL PET/ CT scan (PSMA PET)

Group IV: Cohort 4 Experimental Treatment 1 Intervention

Men with biochemical failure after initial radical prostatectomy with or without adjuvant/ salvage radiotherapy who are currently on salvage hormone therapy will be restaged with \[18F\]-DCFPyL PET/ CT scan (PSMA PET)

Group V: Cohort 3 Experimental Treatment 1 Intervention

Men with biochemical failure after initial radical prostatectomy and salvage radiotherapy will be restaged with \[18F\]-DCFPyL PET/ CT scan (PSMA PET)

Group VI: Cohort 2 Experimental Treatment 1 Intervention

Men with biochemical failure after initial prostatectomy will be restaged with \[18F\]-DCFPyL PET/ CT scan (PSMA PET)

Group VII: Cohort 1 Experimental Treatment 1 Intervention

Men who are node positive or who have persistently detectable PSA after initial radical prostatectomy will be restaged with \[18F\]-DCFPyL PET/ CT scan (PSMA PET)

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Centre for Probe Development and Commercialization

Collaborator

Trials

7

Recruited

3,300+

Cancer Care Ontario

Collaborator

Trials

17

Recruited

92,000+

Findings from Research

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 new PET agent 18F-DCFPyL, which targets prostate-specific membrane antigen (PSMA), has shown superior diagnostic accuracy compared to conventional imaging methods for staging and restaging prostate cancer, as demonstrated in the OSPREY and CONDOR clinical trials.

The use of PSMA-PET imaging is expected to significantly enhance prostate cancer management and may lead to new diagnostic and therapeutic opportunities, improving overall patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Piflufolastat F-18 (18F-DCFPyL) for PSMA PET imaging in prostate cancer . Voter, AF., Werner, RA., Pienta, KJ., et al.[2022]

18F-DCFPyL (piflufolastat F 18) is the first PSMA-targeted PET agent approved for imaging prostate cancer, demonstrating high affinity for PSMA and becoming the standard-of-care for primary staging and recurrent disease.

The approval of 18F-DCFPyL was based on two significant multi-center trials, OSPREY and CONDOR, which focused on high-risk primary staging and biochemical recurrence, respectively, highlighting its efficacy in identifying prostate cancer metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image acquisition and interpretation of 18F-DCFPyL (piflufolastat F 18) PET/CT: How we do it. Rowe, SP., Voter, AF., Werner, RA., et al.[2023]

In a study of 235 patients undergoing F-18 PSMA PET imaging for prostate cancer, 65.5% had PSMA-avid lesions detected, indicating its effectiveness in identifying cancer spread.

The imaging led to changes in treatment plans for 54.5% of patients in the initial staging group and 33.9% in the biochemical recurrence group, demonstrating its significant impact on clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of piflufolastat F-18 PSMA PET imaging on clinical decision-making in prostate cancer across disease states: A retrospective review. Arafa, AT., Jain, A., Skrobanek, P., et al.[2023]

Piflufolastat F 18 (PYLARIFY®) is a newly approved diagnostic imaging agent that targets prostate-specific membrane antigen (PSMA) for use in PET scans, specifically for detecting prostate cancer lesions.

Approved in the USA on May 27, 2021, Piflufolastat F 18 is intended for men with prostate cancer who have suspected metastasis or recurrence, providing a valuable tool for guiding treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Piflufolastat F 18: Diagnostic First Approval. Keam, SJ.[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]

References

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

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

2. England pubmed.ncbi.nlm.nih.gov

Piflufolastat F-18 (18F-DCFPyL) for PSMA PET imaging in prostate cancer . [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Image acquisition and interpretation of 18F-DCFPyL (piflufolastat F 18) PET/CT: How we do it. [2023]

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

Impact of piflufolastat F-18 PSMA PET imaging on clinical decision-making in prostate cancer across disease states: A retrospective review. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Piflufolastat F 18: Diagnostic First Approval. [2022]

6. 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]