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

NCT02856100 | Completed

• 2 other identifiers: J15232IRB00082289
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Change in number of metastatic lesions detected on 18F-DCFPyL PET/CT

  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)

  up to 2 years

Study Arms (1)

Patients with CRPC, evidence of metastases, planned treatment

Drug: 18F DCFPyL- Radiopharmaceutical

Interventions

18F DCFPyL- Radiopharmaceutical DRUG

Patients with CRPC, evidence of metastases, planned treatment

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Prostate Cancer Foundation: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Steven Rowe, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 4, 2016
• Study Start: August 3, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: May 7, 2020

Record last verified: 2020-05

Locations

US (1)