Status:

TERMINATED

An Investigational Scan (18F-Fluciclovine PET-CT) for the Measurement of Therapeutic Response in Patients With Metastatic Prostate Cancer

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Metastatic Prostate Carcinoma

Stage IVB Prostate Cancer AJCC v8

Eligibility:

MALE

18+ years

Phase:

PHASE4

Brief Summary

This phase IV trial studies how well an investigational scan (18F-fluciclovine PET-CT) works for the measurement of therapeutic response in patients with prostate cancer that has spread to other place...

Detailed Description

PRIMARY OBJECTIVE: I. Evaluate metabolic response by fluciclovine F18 (18F-fluciclovine) PET qualitatively and semi-quantitatively with standardized uptake values (SUV) following androgen deprivation...

Eligibility Criteria

Inclusion

  • Histologically or cytologically proven prostate carcinoma
  • Documented evidence of M1 disease by American Joint Committee on Cancer (AJCC) staging by bone scan, CT and magnetic resonance imaging (MRI)
  • Castration naive disease, no prior systemic therapy for prostate cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Ability to understand and willingness to sign informed consent

Exclusion

  • Known brain metastasis
  • Small cell carcinoma of the prostate

Key Trial Info

Start Date :

September 19 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 28 2022

Estimated Enrollment :

2 Patients enrolled

Trial Details

Trial ID

NCT04134208

Start Date

September 19 2019

End Date

June 28 2022

Last Update

January 16 2025

Active Locations (1)

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1

M D Anderson Cancer Center

Houston, Texas, United States, 77030