18F-DCFPyL Imaging for Prostate Cancer

Overseen By Debbie-Ann N Nathan, R.N.

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must be taking: Androgen deprivation therapy

Disqualifiers: Prior prostate cancer treatment, 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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Varies based on treatment plan

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an imaging agent called 18F-DCFPyL (a type of PET/CT scan) can enhance the detection of prostate cancer response to standard treatments like radiation therapy. Researchers seek to identify medium- and high-risk prostate cancer early, potentially improving treatment outcomes. The trial seeks participants who have been newly diagnosed with prostate cancer, show no signs of cancer spread, and plan to undergo specific radiation therapy, possibly alongside hormone therapy. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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, you will be asked about the medications you are using, so it's best to discuss this with the trial team.

What prior data suggests that 18F-DCFPyL imaging is safe for prostate cancer detection?

Research has shown that 18F-DCFPyL is safe and well-tolerated in people. One study found that patients experienced no serious side effects when this imaging agent was used in PET/CT scans. Another study demonstrated that 18F-DCFPyL effectively detected recurrent prostate cancer and was safe for participants. Overall, these findings suggest that 18F-DCFPyL does not cause significant negative effects, making it a promising option for imaging in prostate cancer cases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 18F-DCFPyL imaging for prostate cancer because it offers a novel way to detect cancerous cells with greater precision. Unlike traditional imaging methods, such as multiparametric MRI (mpMRI), 18F-DCFPyL is a radiotracer that specifically targets the prostate-specific membrane antigen (PSMA) found on prostate cancer cells. This targeted approach potentially allows for more accurate identification of cancer spread, which can lead to better treatment decisions. Additionally, this method may detect cancer at earlier stages, improving patient outcomes.

What evidence suggests that 18F-DCFPyL imaging is effective for detecting prostate cancer response?

Research shows that 18F-DCFPyL, used in PET scans, is a strong tool for finding prostate cancer. Studies have found it to be very accurate in spotting cancer cells. This imaging agent can detect both new prostate cancer and cases where the cancer has returned, even when PSA levels are low. In this trial, participants will undergo 18F-DCFPyL imaging alongside routine imaging (mpMRI). Using 18F-DCFPyL has led to changes in treatment plans because doctors find it very helpful in managing prostate cancer. Overall, these findings suggest that 18F-DCFPyL is a promising way to improve the detection and treatment planning for prostate cancer. ^{3 6 7 8 9}

Who Is on the Research Team?

Deborah Citrin, MD

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

This trial is for men aged 18+ with newly diagnosed localized prostate cancer, planning to undergo SBRT possibly with ADT. They must have an ECOG status of <=2, use contraception if applicable, and can't have prior prostate cancer treatments. HIV-positive participants are eligible if virally suppressed.

Inclusion Criteria

My hepatitis C is cured or currently treated with no detectable virus.

I have prostate cancer confirmed by MRI and biopsy.

My hepatitis B virus load is undetectable with treatment.

Exclusion Criteria

My cancer has spread beyond the prostate.

I cannot undergo radiation or SBRT due to health reasons.

I have had hormone therapy, radiation, or surgery for prostate cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Imaging

Participants will have baseline MRI and PET/CT scans with 18F-DCFPyL

1 week

1 visit (in-person)

Treatment

Participants receive SBRT with or without ADT

Varies based on treatment plan

Multiple visits (in-person)

Post-Treatment Imaging

Participants undergo 18F-DCFPyL PET/CT and mpMRI 6 months following completion of SBRT

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits 1 month after treatment, then every 3 months for a year, and then every 6 months for 1 more year

2 years

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 18F-DCFPyL

Trial Overview Researchers are testing the effectiveness of a PET scan imaging agent called 18F-DCFPyL in detecting how well standard prostate cancer treatment works. Participants will undergo MRI and PET/CT scans before and after receiving SBRT (with or without ADT) to assess treatment response.

How Is the Trial Designed?

Group I: 18F-DCFPyL imaging Experimental Treatment 1 Intervention

18F-DCFPyL imaging with routine imaging (mpMRI)

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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 30 patients with intermediate to high-risk primary prostate cancer, 18F-DCFPyL-PET/CT demonstrated a high accuracy in localizing clinically significant prostate cancer (csPCa), with a detection rate of 93% for recommended biopsy segments.

The diagnostic performance of 18F-DCFPyL-PET/CT showed a sensitivity of 61.4% and specificity of 88.3% for identifying csPCa, indicating its potential as a valuable tool for guiding targeted prostate biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of prostate cancer with 18F-DCFPyL PET/CT compared to final histopathology of radical prostatectomy specimens: is PSMA-targeted biopsy feasible? The DeTeCT trial. Bodar, YJL., Jansen, BHE., van der Voorn, JP., et al.[2021]

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 of 26 patients with high-risk localized prostate cancer, 18F-DCFPyL PET/CT demonstrated a high sensitivity of 90.9% for detecting tumors, which is comparable to the 86.4% sensitivity of multiparametric MRI (mpMRI).

The PET/CT imaging not only identified tumors that mpMRI missed but also showed significantly higher uptake in tumor tissue compared to nonmalignant tissue, indicating its potential for better disease characterization and correlation with cancer severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Evaluation of 18F-DCFPyL PET/CT in Detection of High-Risk Localized Prostate Cancer: Comparison With mpMRI. Gaur, S., Mena, E., Harmon, SA., et al.[2022]

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 56 patients with suspected prostate cancer, the novel radiotracer 18F-DCFPyL demonstrated high sensitivity (90%) and specificity (100%) for detecting prostate cancer, making it a reliable diagnostic tool.

The imaging results showed a strong correlation between the radiotracer uptake (measured by SUVmax and SULmax) and serum PSA levels, indicating that 18F-DCFPyL PET/CT is effective for initial diagnosis and lymph node staging in suspected prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of 18F-DCFPyL PET/CT in patients with suspected prostate cancer. Zhang, T., Yang, S., Lin, L., 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 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]

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 ... This study showed that 18F-DCFPyL PET/CT had high sensitivity and specificity for the diagnosis of prostate cancer. At present, with the ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251575

Comparison of [¹⁸F]PSMA-1007, [¹⁸F]DCFPyL, and [⁶⁸Ga ... [¹⁸F]PSMA-1007 excels in low PSA settings but risks false positives, while [¹⁸F]DCFPyL offers high detection and flexibility. Tailored tracer ...

4. urotoday.com urotoday.com/conference-highlights/asco-gu-2025/asco-gu-2025-prostate-cancer/158202-asco-gu-2025-early-detection-of-recurrent-prostate-cancer-using-18f-dcfpyl-pet-ct-in-patients-with-minimal-psa-levels.html

Early Detection of Recurrent Prostate Cancer Using 18F- ... 18 F-DCFPyL PET/CT demonstrates a significant detection rate for recurrent prostate cancer in patients with minimally detectable PSA levels.

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2020.38.15_suppl.5501

Impact of PSMA-targeted imaging with 18F-DCFPyL-PET ... PyL-PET/CT led to changed management plans in the majority of pts, thus providing evidence that clinicians find PSMA PET imaging useful in men ...

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

Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with ... Performance of 18F-DCFPyL-PET/CT achieved the study's primary endpoint, demonstrating disease localization in the setting of negative standard imaging and ...

7. 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 ...

8. jnm.snmjournals.org jnm.snmjournals.org/content/60/11/1587

A Prospective Study on 18 F-DCFPyL PSMA PET/CT Imaging ... F-DCFPyL PET/CT imaging identified sites of recurrent prostate cancer in most subjects and was well tolerated, with no serious adverse events. A ...

9. urotoday.com urotoday.com/conference-highlights/asco-gu-2020/asco-gu-2020-prostate-cancer/119096-psma-targeted-18f-dcfpyl-pet-ct-imaging-in-patients-with-prostate-cancer-osprey.html

PSMA-targeted 18F-DCFPyL PET/CT Imaging in Patients ... Overall, the results from this prospective, multi-center, central reader blinded study indicated that 18F-DFPyL is safe and well-tolerated in ...