PSMA PET Scans for Prostate Cancer

Not currently recruiting at 8 trial locations

Overseen By Deaglan McHugh, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Non-prostate malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special type of PET scan, called a PSMA PET scan, can detect prostate cancer more effectively than standard imaging methods. Participants will receive one of two PSMA-targeting imaging agents, 18F-DCFPyL-iPSMA or 68Ga-HBED-iPSMA, to assess if these scans provide clearer images of their cancer. This trial suits men with confirmed prostate cancer, whether newly diagnosed or showing progression, and who have evidence of the disease from standard imaging tests. Participants should plan to start a treatment strategy after the imaging.

As a Phase 2 trial, this research measures how well the imaging works in an initial, smaller group of people, offering participants a chance to contribute to advancements in prostate cancer diagnostics.

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

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.

What prior data suggests that these PSMA PET scans are safe for imaging prostate cancer?

Research has shown that both 18F-DCFPyL-iPSMA and 68Ga-HBED-iPSMA are safe for humans. Studies have found that 18F-DCFPyL-iPSMA is generally well-tolerated, with only mild side effects that completely resolved. The FDA has approved this treatment for certain prostate cancer patients, supporting its safety.

Similarly, tests have confirmed the safety of 68Ga-HBED-iPSMA. No serious unexpected medical problems were reported, and no patients discontinued treatment due to side effects. This treatment also holds FDA approval for prostate cancer patients, reinforcing its safety.

Both treatments effectively detect prostate cancer with high accuracy and reliability, while maintaining a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these PSMA PET scans for prostate cancer because they offer a highly targeted way to detect cancer cells. Unlike standard imaging options, these PET scans use specific tracers, 18F-DCFPyL and 68Ga-HBED, that bind to the PSMA protein found on prostate cancer cells, providing more detailed images. This precision could lead to earlier and more accurate detection of cancer spread, potentially improving treatment decisions and outcomes for patients.

What evidence suggests that these PSMA PET scans are effective for imaging prostate cancer?

This trial will compare the effectiveness of two imaging agents for prostate cancer. Studies have shown that both 18F-DCFPyL and 68Ga-HBED-iPSMA are promising tools for imaging prostate cancer. Participants may receive the 18F-DCFPyL PSMA PET scan, which effectively detects prostate cancer with a detection rate of about 92%. It can locate cancer in the prostate, lymph nodes, and other areas that regular scans might miss. Alternatively, participants may receive the 68Ga-HBED-iPSMA PET scan, which has an accuracy rate of 84% to 92% in correctly identifying prostate cancer. These scans help doctors determine the cancer's location and extent, which is crucial for planning treatment. ^{5 6 7 8 9}

Who Is on the Research Team?

Heiko Schoder, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients with histologically confirmed prostate cancer, that is either: newly diagnosed OR progressive as defined by standard PCWG3 criteria. note that metastatic disease is defined by either bone scintigraphy or by CT or MRI, or a combination of these tests, but not exclusively by molecular imaging criteria.

Patients with newly diagnosed localized or metastatic prostate cancer are eligible, provided standard imaging (either bone scintigraphy, CT or MRI) demonstrates evidence of radiographic disease

Patient with progressive disease that is non-metastatic are eligible by biochemical progression: A minimum of three rising PSA values from a baseline that are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo PSMA PET scans to assess prostate cancer imaging

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 18F-DCFPyL-iPSMA
• 68Ga-HBED-iPSMA

How Is the Trial Designed?

Group I: Prostate cancer Experimental Treatment 3 Interventions

Participants with histologically confirmed prostate cancer, that is either newly diagnosed OR progressive as defined by standard PCWG3 criteria. Patients w ill remain on study until 30 days after their last PSMA imaging timepoint required by their companion therapeutic protocol.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Progenics Pharmaceuticals, Inc.

Industry Sponsor

Trials

35

Recruited

4,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10030046/

The diagnostic performance of 18F-DCFPyL PET in ... 18 F-DCFPyL PSMA PET has a strong predictive value for primary prostate cancer and is an effective method for the non-invasive diagnosis of prostate cancer.

2. 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.

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. 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, ...

5. aacrjournals.org aacrjournals.org/clincancerres/article/27/13/3674/671523/Diagnostic-Performance-of-18F-DCFPyL-PET-CT-in-Men

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

6. 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 ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.TPS5101

A study of prospective monitoring of patients with recurrent ... Background: 18F-DCFPyL PSMA PET imaging is now FDA approved for patients with high-risk prostate cancer and those with biochemically ...

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

Initial Evaluation of [18F]DCFPyL for Prostate-Specific ... [18F]DCFPyL is safe with biodistribution as expected, and its accumulation is high in presumed primary and metastatic foci. The radiation dose from [18F]DCFPyL ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02151760

NCT02151760 | Study of 18F-DCFPyL, a Second ... This study is being done to determine the safety, biodistribution, and radiation dosimetry of 18F-DCFPyL, and to detect prostate cancer by visual analysis.