PSMA-Based PET Imaging for Prostate Cancer

Not currently recruiting at 6 trial locations

Overseen By Michele L Reed, R.N.

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Investigational agents, Hormone therapy

Disqualifiers: Metastatic disease, Prior prostate therapy, 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: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a PET/CT scan can predict the return of prostate cancer after prostate gland removal surgery. The goal is to determine if this scanning method is more accurate than current standard methods. Men with prostate cancer that appears to have spread outside the prostate but still seems contained may be suitable for the trial. Participants will receive an injection of the tracer 18F-DCFPyL (also known as PyL-PSMA-11) for the scan, followed by surgery and several years of follow-up. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in prostate cancer care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have taken any investigational agents in the past 28 days or have had hormone therapy for prostate cancer, except for limited use of androgen receptor antagonists.

What prior data suggests that this PET/CT scan is safe for prostate cancer imaging?

Research has shown that 18F-DCFPyL PET/CT scans are generally well-tolerated by patients. In studies of this imaging method, most participants experienced no serious side effects, suggesting that the scans are generally safe. The radiotracer 18F-DCFPyL, used in these scans, helps detect cancer that might not appear on regular imaging tests. Evidence indicates that these scans effectively find cancer, making them a promising tool without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 18F-DCFPyL for prostate cancer because it offers a new way to detect cancer cells. This treatment uses a PSMA-based PET imaging technique that specifically targets prostate-specific membrane antigen (PSMA), which is often found in high levels on prostate cancer cells. Unlike traditional imaging methods, 18F-DCFPyL can provide more precise images, potentially leading to better detection and treatment planning. Additionally, its ability to combine with radical prostatectomy and lymphadenectomy could improve surgical outcomes by more accurately identifying cancerous tissues.

What evidence suggests that this PET/CT scan is effective for predicting prostate cancer recurrence?

Research shows that the 18F-DCFPyL PET/CT scan, which participants in this trial will undergo, effectively diagnoses prostate cancer. Studies have found it reliably predicts the presence of cancer. This scan excels at accurately detecting prostate cancer and confirming its absence. As a non-invasive method, it also helps predict the likelihood of prostate cancer returning after surgery, offering a more precise approach than standard imaging methods like CT or MRI alone. ^{4 6 7 8 9}

Who Is on the Research Team?

Fatima H Karzai, M.D.

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

Men over 18 with high-risk prostate cancer that's likely still in the prostate but could have spread. They must be healthy enough for surgery, able to undergo certain scans and biopsies if needed, and not have had any prior treatments or other cancers within 3 years.

Inclusion Criteria

I am planning to have surgery to remove my prostate and lymph nodes.

Ability of subject to understand and the willingness to sign a written informed consent document.

Willingness and ability to undergo multiparametric prostate MRI and 18F-DCFPyL PET/CT

Exclusion Criteria

I have had treatment for prostate cancer, including surgery, radiation, or chemotherapy.

I have had hormone therapy for prostate cancer, but only short-term androgen blocker use.

My scans show cancer has spread to distant parts of my body, but small pelvic lymph nodes are okay.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Imaging and Pre-Surgery

Participants undergo 18F-DCFPyL PET/CT imaging and other baseline assessments before surgery

Up to 60 days

1 visit (in-person)

Surgery

Participants undergo radical prostatectomy and lymphadenectomy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for progression and response to treatment

5 years

5 visits in the first year, 2 visits in the second year, then annually

What Are the Treatments Tested in This Trial?

Interventions

• 18F-DCFPyL

Trial Overview The trial is testing a new PET/CT scan using the tracer 18F-DCFPyL before removing the prostate gland to see if it can predict cancer recurrence better than current methods. Participants will be followed up for five years after surgery.

How Is the Trial Designed?

Group I: 1/18F-DCFPyL PET/CT + radical prostatectomy Experimental Treatment 1 Intervention

18F-DCFPyL PET/CT with radical prostatectomy and lymphadenectomy

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Lantheus

Collaborator

Trials

1

Recruited

180+

Published Research Related to This Trial

The study demonstrated that the 18F-DCFPyL PET imaging can effectively distinguish malignant prostate cancer from benign tissue, with significant differences in uptake values observed as early as 5 minutes post-injection in 10 patients with high-risk prostate cancer.

The pharmacokinetic analysis revealed that malignant prostate tissue had a 15-fold higher influx value (Ki) compared to benign prostatic hyperplasia and normal prostate tissue, indicating that 18F-DCFPyL PET imaging can be a valuable tool for early detection of prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of Dynamic 18F-DCFPyL PET/CT Imaging of Prostate Adenocarcinoma in High-Risk Primary Prostate Cancer Patients. Lu, M., Lindenberg, L., Mena, E., et al.[2023]

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 automated synthesis of the radiotracer [(18)F]DCFPyL for PET imaging of prostate cancer was successful, yielding a good radiochemical yield of 23% in just 55 minutes, making it suitable for clinical applications.

[(18)F]DCFPyL demonstrated high uptake in PSMA-positive LNCaP tumors, with a two-step molecular trapping mechanism confirmed, indicating its potential effectiveness for targeted imaging in prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated synthesis of [(18)F]DCFPyL via direct radiofluorination and validation in preclinical prostate cancer models. Bouvet, V., Wuest, M., Jans, HS., 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 synthesized imaging agent [(18)F]DCFPyL effectively targets the prostate-specific membrane antigen (PSMA), showing a strong binding affinity (K(i) value of 1.1 nmol/L) and high uptake in PSMA-positive prostate tumors in mouse models.

[(18)F]DCFPyL demonstrated significant tumor delineation in PET imaging, with a remarkable uptake ratio of 358:1 between PSMA-positive and PSMA-negative tumors, indicating its potential as a specific imaging tool for prostate cancer with minimal uptake in non-target tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2-(3-{1-Carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid, [18F]DCFPyL, a PSMA-based PET imaging agent for prostate cancer. Chen, Y., Pullambhatla, M., Foss, CA., 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]

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]

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]

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 ... In summary, the 18F-DCFPyL PET/CT method had high efficiency in diagnosing prostate cancer. CT and MRI were useful non-invasive methods for ...

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. 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 ...

5. nature.com nature.com/articles/s41598-023-35567-w

Scientific Reports 18 F]DCFPyL PET/CT is a new imaging modality to evaluate PC patients with higher sensitivity and specificity in detecting disease than other prostate specific ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5261857/

PSMA-Based [18F]DCFPyL PET/CT Is Superior to ... PSMA-based PET/CT with the second-generation radiotracer [18F]DCFPyL was able to identify a large number of putative sites of metastatic prostate cancer that ...

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

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