Comparison of PSMA-based 18F-DCFPyL PET/CT to Conventional Imaging in the Evaluation of Patients With Castration-Resistant Prostate Cancer

• ClinicalTrials.gov Identifier: NCT02856100
• Recruitment Status: Completed
• First Posted: August 4, 2016
• Last Update Posted: May 7, 2020
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Prostate Cancer Foundation
• Information provided by (Responsible Party): Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information

• First Submitted Date: August 2, 2016
• First Posted Date: August 4, 2016
• Last Update Posted Date: May 7, 2020
• Actual Study Start Date: August 3, 2016
• Actual Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 18, 2018)

Change in number of metastatic lesions detected on 18F-DCFPyL PET/CT [ Time Frame: up to 2 years ]

Change in number of metastatic lesions detected from baseline standard of care conventional imaging (CT and Bone Scan) to 18F-DCFPyL PET/CT at 8-12 weeks post- anti-androgen therapy (standard of care)

• Original Primary Outcome Measures (submitted: August 2, 2016): Compare metastatic lesions detected on 18F-DCFPyL PET/CT at baseline and follow-up with standard of care conventional imaging (CT and bone scan) response at 8-12 weeks [ Time Frame: within 2 years of imaging ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of PSMA-based 18F-DCFPyL PET/CT to Conventional Imaging in the Evaluation of Patients With Castration-Resistant Prostate Cancer
• Official Title: Comparison of PSMA-based 18F-DCFPyL PET/CT to Conventional Imaging in the Evaluation of Patients With Castration-Resistant Prostate Cancer
• Brief Summary: We intend to validate 18F-DCFPyL for imaging patients with metastatic, castrate-resistant PCa (CRPC), so that it may be used to full advantage in supporting existing and emerging therapies for a spectrum of patients suffering from PCa. In this study we will image patients with CRPC undergoing second-line anti-androgen therapy (enzalutamide or abiraterone) using 18F-DCFPyL-PET/CT for detection of metastases and therapeutic monitoring, with correlation to standard-of-care conventional imaging modalities (CIM) (CT, bone scan) and clinical follow-up.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients with CRPC and planned treatment with evidence of metastases on conventional imaging modality (CIM) (CT and/or bone scan)
• Condition: Prostate Cancer
• Intervention: Drug: 18F DCFPyL- Radiopharmaceutical

Study Groups/Cohorts

Patients with CRPC, evidence of metastases, planned treatment

Intervention: Drug: 18F DCFPyL- Radiopharmaceutical

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 5, 2020): 18
• Original Estimated Enrollment (submitted: August 2, 2016): 20
• Actual Study Completion Date: January 2020
• Actual Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Willing and able to provide written informed consent
• Age ≥ 18 years and male
• Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
• Patients starting abiraterone (but naïve to enzalutamide) or starting enzalutamide (but naïve to abiraterone)
• Prior docetaxel-based chemotherapy is permitted but not required

• Documented metastatic prostate cancer progression as assessed by the treating oncologist with either one or both of the following:

  • Rising PSA over a minimum 1-week interval
  • Radiographic progression in soft tissue and/or bone
• Ongoing androgen deprivation with serum testosterone < 50 ng/dL (< 1.7 nM)
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
• Hemoglobin ≥ 90 g/L independent of transfusion
• Platelet count ≥ 100,000/μL
• Serum albumin ≥ 30 g/L
• Serum creatinine < 1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min
• Serum potassium ≥ 3.5 mmol/L

Exclusion Criteria:

• Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection

• Abnormal liver functions consisting of any of the following:

  • Serum bilirubin ≥ 1.5 x ULN (except for patients with documented Gilbert's disease)
  • AST or ALT ≥ 2.5 x ULN, (for patients with known liver metastasis, AST or ALT ≤ 5 x ULN is allowed)
• Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg)
• Active or symptomatic viral hepatitis or chronic liver disease
• History of pituitary or adrenal dysfunction
• Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or cardiac ejection fraction measurement of < 50 % at baseline
• Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 12 months
• Known brain metastasis
• History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of orally administered hormonal agents.
• Acute toxicities due to prior chemotherapy and/or radiotherapy that have not resolved to a NCI CTCAE (version 4.0) grade of ≤ 1; chemotherapy-induced alopecia and grade 2 peripheral neuropathy are allowed
• Current enrollment in an investigational drug or device study, or participation in such a study within 30 days of first administration of the hormonal agent.
• Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
• Not willing to comply with the procedural requirements of this protocol
• Patients who have partners of childbearing potential who are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 13 weeks after last study drug administration
• Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 120 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02856100
• Other Study ID Numbers: J15232; IRB00082289 ( Other Identifier: JHMIRB )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Original Responsible Party: Same as current
• Current Study Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Original Study Sponsor: Same as current
• Collaborators: Prostate Cancer Foundation

Investigators

• Principal Investigator: Steven Rowe, MD, PhD; Johns Hopkins University

• PRS Account: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Verification Date: May 2020