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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
18F-DCFPyL
Sponsored by
Ashok Muthukrishnan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • UPMC Hillman Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-DCFPyL + PET imaging

Arm Description

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.)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Positive predictive value (PPV) (per-region)
Number of true positive scans (TP - positive test with disease) divided by number of TP plus number of false positive scans (FP - positive test without true disease), by region (prostate bed, locoregional lymph nodes, distant lymph nodes, bones, and/or visceral organs). 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.

Full Information

First Posted
January 22, 2021
Last Updated
March 1, 2023
Sponsor
Ashok Muthukrishnan
Collaborators
Progenics Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04727736
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ashok Muthukrishnan
Collaborators
Progenics Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-DCFPyL + PET imaging
Arm Type
Experimental
Arm Description
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.)
Intervention Type
Drug
Intervention Name(s)
18F-DCFPyL
Intervention Description
18F-DCFPyL (single dose injection) - a radiolabeled prostate-specific membrane antigen (PSMA) ligand
Primary Outcome Measure Information:
Title
Positive predictive value (PPV) (per-patient)
Description
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.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Positive predictive value (PPV) (per-region)
Description
Number of true positive scans (TP - positive test with disease) divided by number of TP plus number of false positive scans (FP - positive test without true disease), by region (prostate bed, locoregional lymph nodes, distant lymph nodes, bones, and/or visceral organs). 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.
Time Frame
Up to 12 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Intermediate or High Risk Biochemically Recurrent Prostate Cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashok Muthukrishnan, MD, MS
Organizational Affiliation
University of Pittsburgh - Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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