18F-DCFPyL Positron Emission Tomography (PET) in Intermediate or High Risk Prostate Cancer

NCT04727736 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: HCC 20-009
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This is an interventional, single group assignment, prospective nonrandomized, open label Phase 2 trial designed to evaluate 18F-DCFPyL PET imaging in men diagnosed with prostate cancer with increasing prostate-specific antigen (PSA) levels.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Positive Predictive Value (PPV) (Per-patient)

  Number of patients with true positive scans (TP - positive test with disease) divided by number of TP plus number of false positive scans (FP - positive test without disease). A scan will be deemed 'positive' if at least one lesion suggestive of disease recurrence is noted. Prostate lesions and lymph nodes will be considered positive if the uptake in those lesions exceeds blood pool activity. Bone lesions will be recorded as positive if the activity is higher than normal bone marrow uptake.

  Up to 12 months

Secondary Outcomes (1)

• Positive Predictive Value (PPV) (Per-region)

  Up to 12 months

Study Arms (1)

18F-DCFPyL + PET imaging

EXPERIMENTAL

Participants will receive a single dose of 18F-DCFPyL and undergo a PET imaging study. (The PET imaging may be repeated at a later date if the biopsy of the lesion is negative and if the lesion is present on follow-up imaging.)

Drug: 18F-DCFPyL

Interventions

18F-DCFPyL DRUG

18F-DCFPyL (single dose injection) - a radiolabeled prostate-specific membrane antigen (PSMA) ligand

18F-DCFPyL + PET imaging

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Intermediate or High Risk Biochemically Recurrent Prostate Cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of prostate cancer
• Biochemical recurrence was defined as a PSA of 0.2 or more ng/mL measured more than 6 weeks after prostatectomy or a PSA of 2 or more ng/mL rise above nadir following radiation therapy (ASTRO Phoenix consensus definition)
• Age ≥ 18 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
• Ability to understand and willingness to sign a written informed consent document
• Willing to comply with clinical trial instructions and requirements

You may not qualify if:

• History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin
• Presence of prostate brachytherapy implants unless approved by the PI
• Administration of another radioisotope within five physical half-lives of trial enrollment
• Radiation or chemotherapy within 2 weeks prior to trial enrollment
• Estimated glomerular filtration rate (eGFR) \< 15 ml/mmol
• Serum total bilirubin \> 3 times the upper limit of normal
• Aspartate transaminase (AST) or alanine aminotransferase (ALT) \> 5 times the upper limit of normal
• Inadequate venous access
• Claustrophobia or any other condition that would preclude PET imaging
• Patients must not be receiving ADT except per criteria directly below. Patients who received in the past must have a serum testosterone that is recovered to at least 100 ng/dL.
• Patients who have been on ADT +/- novel hormonal agent (NHA) and developed M0 CRPC

Sponsors & Collaborators

• Ashok Muthukrishnan: lead
• Progenics Pharmaceuticals, Inc.: collaborator

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Barbara M Stadterman, Clinical Research Manager - Regulatory
• Organization: UPMC Hillman Cancer Center

stadtermanbm@upmc.edu

412-647-5554

Study Officials

• Ashok Muthukrishnan, MD, MS

  University of Pittsburgh - Associate Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 27, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 15, 2024
• Results First Posted: February 15, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)