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: 6

3070 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to scan for recurrent prostate cancer using a special type of PET/CT scan called [18F]-DCFPyL (also known as Piflufolastat F 18 or Pylarify). The goal is to better understand how prostate cancer recurs after initial treatment, aiding doctors in tailoring future treatments. Men who have undergone treatment for prostate cancer and show signs of recurrence may be suitable for this trial. Researchers will divide participants into groups based on their previous treatments and current condition to assess the scan's effectiveness in different scenarios. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future prostate cancer care.

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 prior data suggests that this PSMA-PET scan is safe for recurrent prostate cancer?

Research shows that the [18F]-DCFPyL PET/CT scan is generally safe. Studies have found that this imaging method is well-tolerated. The PET scan uses a tracer called [18F]-DCFPyL, which highlights prostate cancer during the scan.

In early tests, participants who underwent scans with the [18F]-DCFPyL tracer did not experience serious side effects, suggesting the procedure is safe for most patients. The tracer has been used in other cases and is FDA-approved for imaging prostate cancer, further supporting its safety.

While every medical procedure carries some risks, data indicate that adverse reactions are rare with this PET scan. Discuss any concerns with a healthcare provider before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the [18F]-DCFPyL PET/CT scan for recurrent prostate cancer because it offers a more precise way to detect cancer spread compared to traditional imaging techniques like bone scans or CT scans. Unlike standard imaging methods, this scan specifically targets the PSMA protein, which is often overexpressed in prostate cancer cells, allowing for better visualization of cancerous lesions. This improved detection could lead to more tailored treatment plans, potentially improving outcomes for patients with recurrent prostate cancer.

What evidence suggests that the [18F]-DCFPyL PET/CT scan is effective for recurrent prostate cancer?

Research has shown that the [18F]-DCFPyL PET/CT scan, which participants in this trial will undergo, effectively detects recurrent prostate cancer. Studies have found that this scan can identify cancer even when PSA (prostate-specific antigen) levels are low, allowing it to find cancer that other standard imaging tests might miss. The scan uses a special tracer to highlight prostate cancer cells, making it easier to locate the cancer in the body. This can assist doctors in making better treatment decisions. Overall, this imaging method has a high detection rate, offering promise for those with recurrent prostate cancer. ^{6 7 8 9 10}

Who Is on the 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

Are You a Good Fit for This Trial?

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.

My PSA is over 10, and recent scans show 4 or fewer cancer spots or none.

Exclusion Criteria

Prior PSMA PET scan within 6 months of enrollment.

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

I cannot stay still for 60 minutes for a scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Restaging

Participants undergo ]-DCFPyL PET/CT scans to identify areas of prostate cancer recurrence

4 years

Multiple visits across 6 centers

Follow-up

Participants are monitored for outcomes and management changes post-imaging

1 year

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251554

18F-Piflufolastat PET/CT in Patients with Biochemically ... Conclusions: PSMA-targeted 18F-piflufolastat PET/CT detected recurrent disease in the prostate and prostate bed with consistent and high PPVs ( ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9619197/

18F-DCFPyL PET/CT for Initially Diagnosed and ... Prostate-specific membrane antigen (PSMA) PET is standard for newly diagnosed high-risk and biochemically recurrent (BCR) prostate cancer.

3. 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.

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

Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with ... CONDOR was a prospective study designed to determine the performance of 18 F-DCFPyL-PET/CT in patients with BCR and uninformative standard imaging.

5. 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 ...

6. mayoclinic.org mayoclinic.org/tests-procedures/psma-pet-scan/about/pac-20582225

PSMA PET scan for prostate cancer A PSMA PET scan is an imaging test that detects prostate cancer. Learn how it works, why it's done and what results may show.

7. pylarify.com pylarify.com/efficacy-safety/safety

Explore PYLARIFY® Safety Data & Side Effects PYLARIFY is a PSMA-targeted PET imaging agent for prostate cancer. Learn more about PYLARIFY safety data and adverse reactions.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/214793s000lbl.pdf

PYLARIFY® (piflufolastat F 18) injection, for intravenous use PYLARIFY is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: • with ...

9. pylarify.com pylarify.com/

Prostate Cancer Diagnostic Imaging Agent | PYLARIFY® PYLARIFY (piflufolastat F 18) is a PSMA-targeted PET imaging agent for prostate cancer. See indications and learn how PYLARIFY performs at low PSA levels.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4531836/

Initial Evaluation of [18F]DCFPyL for Prostate-Specific ... Data from this initial clinical experience demonstrate that PET imaging with [18F]DCFPyL is feasible and safe. Physiologic accumulation of the radiotracer ...