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FDG Positron Emission Tomography and Computed Tomography (PET-CT) in Metastatic Prostate Cancer

NCT00282906 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2017-04-18

No results posted yet for this study

Summary

This is an National Institute of Health (NIH) funded, investigator-initiated, single center prospective study to investigate the ability of the new dual-modality positron emission tomography and computed tomography (PET-CT) imaging systems in comparison to conventional imaging methods in assessing treatment response in men with metastatic prostate cancer. The investigators will enroll two groups of men with stage IV metastatic prostate cancer, each group will be comprised of 160 patients.

* Group I: men with newly diagnosed hormone-responsive measurable metastatic disease who will be treated with androgen-ablation therapy
* Group II: men with newly-developed hormone-refractory measurable metastatic disease who will be treated with chemotherapy and /or other therapies for hormone refractory disease

To be eligible, men in either group must have rising serum prostate specific antigen (PSA) level - defined as at least 2 consecutive rises in PSA documented over a reference value (1st measure within 28 days prior to recruitment). The first rising PSA (2nd measure) should be taken at least 14 days after the reference value. A confirmatory PSA measure (3rd measure) obtained at least 14 days after the 2nd measure is required and must be greater than the 2nd measure. Additionally, patients must have a serum PSA concentration of at least 2 ng/mL in addition to increasing PSA to be eligible. Patients will be followed with the PET-CT at 4, 8, and 12 months after the initiation of androgen ablation therapy (Group I) or chemotherapy (Group II).

Conditions

Interventions

DEVICE

hybrid PET-CT imaging system

15 mCi of FDG

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • Hossein Jadvar, MD · University of Southern California

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-03
Primary Completion
2013-12-19
Completion
2014-08-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00282906 on ClinicalTrials.gov