PET Imaging for Prostate Cancer

Overseen By Di (Maria) Jiang, M.D.

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must be taking: ADT, ARPI

Must not be taking: Radioisotopes, Investigational agents

Disqualifiers: Active malignancy, Dialysis, others

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

Compensation: Varies

Number of Visits: 1

Duration: Varies based on standard of care

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will use Prostate Specific Membrane Antigen (PSMA) and (18)F-Fluorodeoxyglucose Positron Emission Tomography (FDG PET) imaging in patients with advanced prostate cancer to learn about tumor biology across disease stages and during treatment. This may help with treatment selection and potential response monitoring in the future.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on another radioisotope or investigational systemic agent, you may need to stop it at least 5 half-lives before the PET imaging.

What data supports the effectiveness of the treatment 18F-DCFPyL PET for prostate cancer?

Research shows that 18F-DCFPyL PET is better at detecting prostate cancer lesions compared to traditional imaging methods like CT scans and bone scans. It is particularly useful for identifying cancer that has spread and for managing recurrent prostate cancer, making it a valuable tool in patient care. ^{1 2 3 4 5}

Is 18F-DCFPyL PET imaging safe for humans?

Initial studies on 18F-DCFPyL PET imaging for prostate cancer have shown it to be safe, with research focusing on its distribution in the body and radiation exposure levels in patients. ^{6 7 8 9 10}

How does the drug 18F-DCFPyL differ from other treatments for prostate cancer?

18F-DCFPyL is a novel imaging drug used in PET scans that targets the prostate-specific membrane antigen (PSMA), which is highly expressed in prostate cancer. Unlike conventional imaging methods like CT or MRI, 18F-DCFPyL offers improved detection of prostate cancer spread, especially in lymph nodes and metastatic sites, due to its high specificity and better image resolution. ^{1 2 6 11 12}

Research Team

Di (Maria) Jiang

Principal Investigator

Princess Margaret Cancer Centre/University Health Network

Eligibility Criteria

This trial is for individuals with advanced prostate cancer. It aims to understand tumor biology using specialized imaging techniques, which could guide treatment choices and monitor responses in the future.

Inclusion Criteria

My prostate cancer is advanced and was confirmed by scans before starting hormone therapy.

I am considered high-risk with metastatic castration-sensitive prostate cancer.

I haven't had PSMA or FDG PET scans in the last 60 days.

Exclusion Criteria

Another radioisotope or investigational systemic agent within 5 half-lives prior to PET imaging

Significant uncontrolled comorbidity, which may negatively impact the safety or interpretability of study PET imaging

Inability to undergo or successfully complete PSMA PET and FDG PET imaging exams

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo PSMA and FDG PET imaging to assess tumor biology before starting standard of care treatment

1 week

1 visit (in-person)

Treatment

Participants receive standard of care treatment with ongoing PSMA and FDG PET imaging to monitor response

Varies based on standard of care

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 18F-DCFPyL PET
• FDG PET
• Ga 68 PSMA-11 PET

Trial Overview The study tests the use of two types of PET scans: Ga 68 PSMA-11 and FDG PET, along with a third type called 18F-DCFPyL PET. These scans are used to visualize cancer activity and may inform better treatment strategies.

Participant Groups

Group I: PSMA and FDG PET Imaging Experimental Treatment 3 Interventions

Participants advanced prostate cancer will undergo PSMA and FDG PET prior to starting their standard of care treatment and during treatment.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

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 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]

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 study evaluated the dosimetry of the PET radiotracer 18F-DCFPyL in nine patients with metastatic prostate cancer, revealing that the lacrimal glands received the highest absorbed dose, which is important for understanding potential side effects during imaging and therapy.

Using advanced Monte-Carlo models, the research provided new insights into the dose received by the lacrimal and salivary glands, which are critical for assessing the safety and efficacy of 18F-DCFPyL in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined model-based and patient-specific dosimetry for 18F-DCFPyL, a PSMA-targeted PET agent. Plyku, D., Mena, E., Rowe, SP., et al.[2018]

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]

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 of [(18)F]DCFPyL in nine prostate cancer patients showed that it is safe, with no major adverse events related to the radiotracer observed during the imaging process.

[(18)F]DCFPyL demonstrated high accumulation in prostate cancer sites, indicating effective targeting for imaging, and its radiation dose is comparable to other PET radiotracers, making it a viable option for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Evaluation of [(18)F]DCFPyL for Prostate-Specific Membrane Antigen (PSMA)-Targeted PET Imaging of Prostate Cancer. Szabo, Z., Mena, E., Rowe, SP., et al.[2022]

In a study involving 14 patients with biochemically relapsed prostate cancer, the new fluorine-18 labeled tracer [(18)F]DCFPyL was found to detect all lesions identified by the traditional gallium-68 labeled tracer [(68)Ga]Ga-PSMA-HBED-CC, and additionally revealed extra lesions in three patients.

[(18)F]DCFPyL demonstrated significantly higher image quality, with greater maximum standardized uptake values (SUVmax) and better tumor-to-background ratios compared to [(68)Ga]Ga-PSMA-HBED-CC, suggesting it could be a superior option for PSMA-PET/CT imaging in detecting prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of [(18)F]DCFPyL and [ (68)Ga]Ga-PSMA-HBED-CC for PSMA-PET Imaging in Patients with Relapsed Prostate Cancer. Dietlein, M., Kobe, C., Kuhnert, G., et al.[2021]

References

1. 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]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of 18F-DCFPyL PSMA PET/CT for Prostate Cancer: A Meta-Analysis. [2022]

3. 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]

4. Canada pubmed.ncbi.nlm.nih.gov

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

The diagnostic performance of 18F-DCFPyL PET in patients with suspected prostate cancer: A systemic review and meta-analysis. [2023]

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

Combined model-based and patient-specific dosimetry for 18F-DCFPyL, a PSMA-targeted PET agent. [2018]

7. 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]

8. Germany pubmed.ncbi.nlm.nih.gov

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

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

Initial Evaluation of [(18)F]DCFPyL for Prostate-Specific Membrane Antigen (PSMA)-Targeted PET Imaging of Prostate Cancer. [2022]

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

18F-Labeled Radiotracers for Prostate-specific Membrane Antigen: Historical Perspective and Future Directions. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Pelvic lymph-node staging with 18F-DCFPyL PET/CT prior to extended pelvic lymph-node dissection in primary prostate cancer - the SALT trial. [2023]

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

Comparison of [(18)F]DCFPyL and [ (68)Ga]Ga-PSMA-HBED-CC for PSMA-PET Imaging in Patients with Relapsed Prostate Cancer. [2021]