Clinical trial NCT04727736: 18F-DCFPyL Positron Emission Tomography (PET) in Intermediate or High Risk Prostate Cancer
Official title: Phase 2 Study of 18F-DCFPyL Positron Emission Tomography (PET) in Men With Intermediate or High Risk Biochemically Recurrent Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Progenics Pharmaceuticals, Inc.
First posted: 2021-01-27
Enrollment: 47
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: This is an trial designed to evaluate the positive predictive value of 18F-DCFPyL PET imaging in men diagnosed with prostate cancer with increasing PSA levels. Patients will receive a single dose of 18FDCFPyL PET and undergo a PET imaging study. 18F-DCFPyL Injection is an 18F-labeled small molecule that targets the extracellular domain of PSMA. One intravenous catheter will be placed for radiopharmaceutical administration. Patients will be injected with ≤ 333 MBq (≤ 9 mCi) of 18F-DCFPyL via this catheter. The dose range for 18F-DCFPyL will be 7 - 9 mCi. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Positive Predictive Value (PPV) (Per-patient)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Positive Predictive Value (PPV) (Per-region)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh - Associate Professor
name: Ashok Muthukrishnan, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: