PyL PET/CT Detection for Metastatic Prostate Cancer

(PROSTEP-002 Trial)

Overseen By Marie-Christine Dubé, PhD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: CHU de Quebec-Universite Laval

Must be taking: Androgen deprivation therapy

Must not be taking: Cytotoxic chemotherapy, Abiraterone, Enzalutamide

Disqualifiers: Brain metastasis, Seizure history, Cardiovascular disease, others

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: 2

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aimed to evaluate the diagnostic performance of 18F-DCFPyL (PyL) PET/CT in subjects presenting not previously treated for castration resistant prostate cancer and showing negative or equivocal findings per institutional standard of care conventional imaging

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as specific hormone treatments and investigational drugs, at least 4 weeks before starting the study. It's best to discuss your current medications with the study team to see if any need to be paused.

What data supports the effectiveness of the drug 18F-DCFPyL (PyL) PET/CT for detecting metastatic prostate cancer?

Research shows that 18F-DCFPyL PET/CT is more effective than traditional imaging methods in detecting prostate cancer that has spread, with a high positivity rate and significant impact on treatment decisions for patients with recurrent prostate cancer. ^{1 2 3 4 5}

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

18F-DCFPyL PET/CT is considered safe for use in humans, with studies reporting only mild adverse events that resolved completely. ^{1 4 6 7 8}

How is the drug 18F-DCFPyL PET/CT different from other treatments for metastatic prostate cancer?

The drug 18F-DCFPyL PET/CT is unique because it targets prostate-specific membrane antigen (PSMA) to improve the detection of prostate cancer recurrence and metastasis, offering higher sensitivity and specificity compared to conventional imaging methods like CT and MRI. ^{1 3 4 7 9}

Research Team

Frédéric Pouliot, MD

Principal Investigator

CHU de Québec-Université Laval

Eligibility Criteria

This trial is for men with untreated castration-resistant prostate cancer who have a life expectancy of at least 6 months, ambiguous or negative imaging results, and rising PSA levels despite hormone therapy. They must be candidates for enzalutamide treatment and able to consent to the study. Men currently on certain medications like finasteride or those who've had recent investigational drug therapy are excluded.

Inclusion Criteria

I am a candidate for a specific prostate cancer treatment (like enzalutamide) as my second line of therapy.

Life expectancy ≥6 months as determined by the investigator

My recent scans showed no clear signs of prostate cancer spread.

Exclusion Criteria

Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completing the study.

I haven't taken finasteride or dutasteride in the last 4 weeks.

I haven't had certain types of radiation therapy recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Imaging and Treatment

Participants receive a single dose of 18F-DCFPyL followed by a PET/CT scan. Those with positive imaging are treated with enzalutamide.

2 weeks

1 visit (in-person)

Follow-up Imaging

A repeat 18F-DCFPyL PET/CT scan is conducted 90 days after the start of enzalutamide treatment.

3 months

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

21 months

Treatment Details

Interventions

• 18F-DCFPyL (PyL) PET/CT
• Enzalutamide

Trial Overview The trial is testing how well a diagnostic scan called PyL PET/CT can detect metastases in patients starting on enzalutamide, a medication used for prostate cancer that has resisted other treatments. The performance of this scan will be compared against standard imaging results.

Participant Groups

Group I: Resistant Prostate Cancer and Negative, Equivocal or Oligometastatic Disease on Conventional Imaging Experimental Treatment 1 Intervention

Enrolled subjects will receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL Injection followed by a single PET/CT scan acquired at 1-2 hours post-dosing. After initial 18F-DCFPyL PET/CT, the patients with positive 18F-DCFPyL PET/CT imaging will be treated with enzalutamide (160 mg po id) for M0CRPC disease within less than two weeks. 18F-DCFPyL PET/CT scan will then be repeated 90 days after the start of enzalutamide treatment.

18F-DCFPyL (PyL) PET/CT is already approved in United States for the following indications:

Approved in United States as Pylarify for:

• Detection of suspected metastasis or recurrence in patients with prostate cancer

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

Astellas Pharma Europe Ltd.

Industry Sponsor

Trials

34

Recruited

77,500+

Findings from Research

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]

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 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 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 study evaluated the effectiveness of 18F-DCFPyL PET/CT in detecting recurrent prostate cancer in 77 men, showing high specificity (91%) and positive predictive value (86%) based on histologic validation.

When compared to multiparametric MRI, 18F-DCFPyL PET/CT identified significantly more pelvic lymph nodes (128 vs 23) and improved the positive predictive value by 38% overall, indicating its potential as a superior imaging tool for recurrence detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Biochemically Recurrent Prostate Cancer: Histologic Validation of 18F-DCFPyL PET/CT with Comparison to Multiparametric MRI. Lindenberg, L., Mena, E., Turkbey, B., et al.[2021]

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]

The 18F-DCFPyL PET/CT imaging technique demonstrated a high detection rate of 81% for biochemically recurrent prostate cancer (BRPCa) across nine studies involving 844 patients, indicating its effectiveness as a first-line imaging modality.

The sensitivity of 18F-DCFPyL PET/CT improved significantly with higher prostate-specific antigen (PSA) levels, achieving a detection rate of 88.8% for PSA ≥ 0.5 ng/ml, while it dropped to 47.2% for PSA < 0.5 ng/ml, suggesting its utility in early detection based on PSA stratification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of 18F-DCFPyL PET/CT Imaging in Early Detection of Biochemically Recurrent Prostate Cancer: A Systematic Review and Meta-Analysis. Sun, J., Lin, Y., Wei, X., et al.[2021]

References

1. 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]

2. 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]

3. 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]

4. 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]

5. 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]

6. Germany pubmed.ncbi.nlm.nih.gov

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

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

Evaluating Biochemically Recurrent Prostate Cancer: Histologic Validation of 18F-DCFPyL PET/CT with Comparison to Multiparametric MRI. [2021]

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

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

9. Switzerland pubmed.ncbi.nlm.nih.gov

Performance of 18F-DCFPyL PET/CT Imaging in Early Detection of Biochemically Recurrent Prostate Cancer: A Systematic Review and Meta-Analysis. [2021]