Assessment of Multi-Modality Quantitative Imaging for Evaluation of Response of Metastatic Prostate Cancer to Therapy

Who is this study for? Adult male patients with Prostate Cancer
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The study is an open label, non-randomized study designed to evaluate the diagnostic performance of SPECT CT.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: No
View:

• Males ≥18 years of age. Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.

• Histologically confirmed adenocarcinoma of the prostate. Metastatic castration-resistant prostate cancer (mCRPC) with Bone metastases as manifested by one or more lesions on bone scan.

• Documented castrate level of serum testosterone (≤50 ng/dl).

• Documented progressive mCRPC based on at least one of the following criteria:

• PSA progression defined as 25% increase over baseline value or nadir.

• Radiographic progression for soft tissue lesions as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), and/ or radiographic progression for bone lesions as determined by radionuclide bone scan using the consensus guidelines of the PCWG3 criteria.

• Planning to receive first line novel hormonal therapy with Abiraterone or Enzalutamide for the first time for mCRPC within 4 weeks of documented progression. Baseline scans will be obtained prior to starting new therapy.

Locations
United States
Maryland
Johns Hopkins University
Recruiting
Baltimore
Contact Information
Primary
Rehab AbdAllah, MB BCh
rabdall1@jhmi.edu
443-287-1622
Backup
Lilja Solnes, MD
Time Frame
Start Date: November 15, 2019
Estimated Completion Date: August 15, 2023
Participants
Target number of participants: 60
Treatments
Experimental: Cohort A - SPECT CT and NaF PET
Intervention 1: SPECT CT Intervention 2: NaF PET
Experimental: Cohort B - SPECT CT and 18F-DCFPyL PET/CT
Intervention 1: SPECT CT Intervention 2: 18F-DCFPyL PET/CT
Experimental: Cohort C - SPECT CT and WB-MRI
Intervention 1: SPECT CT Intervention 2: WB-MRI
Related Therapeutic Areas
Sponsors
Leads: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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