PyL PET/CT Detection for Metastatic Prostate Cancer

(PROSTEP-002 Trial)

Not currently recruiting at 5 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging technique, 18F-DCFPyL (PyL) PET/CT, to better detect prostate cancer that has spread and isn't responding to regular hormone therapy. Participants will first receive this special scan, and if the scan reveals cancer, they will be treated with a medication called enzalutamide. The trial seeks men diagnosed with prostate cancer who are currently undergoing hormone therapy and have rising PSA levels (a protein indicating prostate cancer activity) despite treatment. Ideal candidates should have cancer that isn't clearly visible on standard scans. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to benefit from innovative approaches.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the 18F-DCFPyL PET/CT scan is generally easy for patients to handle. Early studies found that this imaging tool, used to detect prostate cancer, is safe. Despite using a small amount of radioactive material, no major safety problems have been reported. Any side effects are usually mild.

For enzalutamide, a treatment for prostate cancer, extensive safety information is available from studies. The FDA has approved this medication for various types of prostate cancer, and it has been used for many years. Most patients tolerate it well, though some might experience fatigue or high blood pressure. These side effects are typically manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because 18F-DCFPyL PET/CT imaging offers a more precise way to detect metastatic prostate cancer compared to conventional imaging methods. This imaging technique uses a special radioactive tracer that binds to prostate-specific membrane antigen (PSMA), allowing for clearer and more detailed scans. Additionally, enzalutamide, an existing treatment, is being tested in combination with this advanced imaging to potentially improve outcomes for patients with resistant prostate cancer. This combination could lead to more tailored and timely treatment strategies, offering hope for better management of the disease.

What evidence suggests that 18F-DCFPyL (PyL) PET/CT is effective for detecting metastatic prostate cancer?

In this trial, participants will receive 18F-DCFPyL (PyL) PET/CT, which studies have shown to effectively detect prostate cancer in about 92% of patients, even when other standard imaging methods fail. Participants with positive 18F-DCFPyL PET/CT imaging will then receive treatment with enzalutamide. Research indicates that enzalutamide significantly benefits prostate cancer patients by reducing the risk of death by 33% and improving survival compared to other treatments. Together, these treatments offer promising results for those with prostate cancer. ^{2 4 6 7 8}

Who Is on the Research Team?

Frédéric Pouliot, MD

Principal Investigator

CHU de Québec-Université Laval

Are You a Good Fit for This Trial?

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

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

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 had certain types of radiation therapy recently.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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. A final follow-up imaging (18F-DCFPyL PET/CT) at progression or at the final follow-up imaging examination at 18 months after the new complete ICF or in September 2026 (whichever comes first) will be performed.

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+

Published Research Related to This Trial

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]

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]

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 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 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 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 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]

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]

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]

Citations

1. pylarify.com pylarify.com/efficacy-safety/diagnostic-performance

Learn About Diagnostic Performance for PYLARIFY® PYLARIFY is a PSMA-targeted PET imaging agent for prostate cancer. Explore the clinical study results to learn more about the diagnostic performance.

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

Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with ... This study was designed to evaluate the performance of 18F-DCFPyL-PET/CT in prostate cancer patients with BCR and non-informative standard-of-care imaging.

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

Evaluation of 18F-DCFPyL PSMA PET/CT for Prostate ... The pooled detection rate (DR) of 18F-DCFPyL PSMA PET/CT in PCa was 92%. The pooled DR was 89% for PSA ≥0.5 ng/ml and 49% for PSA <0.5 ng/ml.

4. lantheusholdings.gcs-web.com lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-announces-presentations-featuring-pylarify

Lantheus Announces Presentations Featuring PYLARIFY ... Data highlights PYLARIFY's ability to detect recurrent prostate cancer in patients with low PSA. Real-world evidence of PYLARIFY's effectiveness in prostate ...

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. 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.

7. 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 ...

8. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.221536

18 F-DCFPyL PET/CT in Men with Prostate Cancer There is evidence supporting the use of 18F-DCFPyL PET in men with castration-sensitive prostate cancer and rising PSA level after prostatectomy ...