Full Text View
Tabular View
No Study Results Posted
Related Studies
[F-18]-Fluorodeoxyglucose (FDG) Positron Emission Tomography and Computed Tomography (PET-CT) in Metastatic Prostate Cancer
This study is currently recruiting participants.
Verified by USC/Norris Comprehensive Cancer Center, July 2009
First Received: January 25, 2006   Last Updated: July 24, 2009   History of Changes
Sponsor: USC/Norris Comprehensive Cancer Center
Information provided by: USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00282906
  Purpose

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-naïve 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

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).


Condition Intervention
Prostate Cancer
Device: hybrid PET-CT imaging system

Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Resource links provided by NLM:


Further study details as provided by USC/Norris Comprehensive Cancer Center:

Primary Outcome Measures:
  • PET/CT imaging validity [ Time Frame: every 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response [ Time Frame: every 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 320
Study Start Date: October 2005
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PET-CT: Experimental Device: hybrid PET-CT imaging system
15 mCi of FDG

Detailed Description:

Our long-range objective is to obtain pilot data to investigate the ability of the new dual-modality positron emission tomography and computed tomography (PET-CT) imaging systems for assessing treatment response in patients with metastatic prostate cancer in comparison to conventional imaging. PET-CT is not employed here for staging; all men in this study will have stage IV metastatic prostate cancer. We believe that the combined anatomic and in-vivo metabolic imaging information provided by PET-CT allows accurate objective assessment of such critical clinical issues as early prediction and evaluation of response or resistance to various therapeutic interventions, including the novel chemotherapy regimen, as well as the prediction of key clinical outcomes such as time to hormone-refractoriness and survival. Our intermediate-range objective is therefore to investigate the diagnostic and prognostic utility of PET-CT with the most commonly available PET tracer, [F-18]-fluorodeoxyglucose (FDG), in metastatic prostate cancer. We plan to correlate the treatment-induced changes of glucose metabolism in metastatic prostate cancer lesions to the changes in various conventional clinical, laboratory, and diagnostic imaging parameters such as serum prostate-specific antigen level, lesion size, time to androgen independence, and survival. This objective is motivated by our preliminary basic science and clinical data as well as the published reports of other investigators demonstrating the pragmatic potential diagnostic and prognostic utility of FDG PET-CT in men with metastatic prostate cancer.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Group-I (hormone-naïve) inclusion criteria:

  • Age > 21 years, men of all ethnic backgrounds
  • Patient must have had a histological diagnosis of adenocarcinoma of prostate and currently must have metastatic disease (stage TxNxM1) that is hormone-naïve.
  • Patients must have conventional imaging evidence for metastatic disease as determined by CT, bone scintigraphy, or both.
  • Patients must have rising serum 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, patient must have a serum PSA concentration of at least 2 ng/mL in addition to increasing PSA to be eligible.

Group-II (hormone-refractory) inclusion criteria:

  • Age > 21 years, men of all ethnic backgrounds
  • Patient must have had a histological diagnosis of adenocarcinoma of prostate and currently must have metastatic disease (stage TxNxM1) that is unresponsive or refractory to hormonal therapy.
  • Progression of measurable disease assessed with CT or bone scan within 28 days prior to recruitment
  • Patients must have rising serum 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, patient must have a serum PSA concentration of at least 2 ng/mL in addition to increasing PSA to be eligible. No minimum PSA level is required for clinically symptomatic patients (e.g. metastasis-related bone pain).
  • Patients must have received prior hormonal therapy and have a castrate level of testosterone. Patients treated with orchiectomy are eligible.

Other general inclusion criteria for both groups:

  • May have received prior surgery (14 days must have elapsed since completion of surgery with recovery from side effects)
  • Creatinine ≤ 2.5 x the institutional upper limit of normal (within 28 days prior to enrollment)
  • Men of childbearing potential must be willing to consent to use effective contraception.
  • Must be competent to consent to study requirements
  • OPTIONAL: Completed baseline McGill Pain Questionnaire and analgesic pain survey. If unable to complete questionnaires in English or Spanish, patient can still participate in this study.

Exclusion Criteria:

  • History of cancer other than prostate cancer (except squamous cell carcinoma of the skin that has been treated with curative intent)
  • Active infection (except mild upper respiratory infections)
  • History of poorly-controlled diabetes mellitus (with Fasting Blood Glucose greater than 200 mg/dL) - in order to avoid false negative results due to glucose competition with [F-18]-Fluorodeoxyglucose in cellular uptake
  • Active inflammatory conditions (e.g. rheumatoid arthritis, sarcoid)
  • History of complicated non-healing fracture
  • Not competent to consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282906

Contacts
Contact: Jennifer Encinas 323/865-3228 jencinas@usc.edu

Locations
United States, California
USC/Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Jennifer Encinas     323-865-3228     jencinas@usc.edu    
Principal Investigator: Hossein Jadvar, MD            
Sponsors and Collaborators
USC/Norris Comprehensive Cancer Center
Investigators
Principal Investigator: Hossein Jadvar, MD USC/Norris Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: University of Southern California ( Dr. Hossein Jadvar )
Study ID Numbers: 4P-05-1, R01CA111613-01A1
Study First Received: January 25, 2006
Last Updated: July 24, 2009
ClinicalTrials.gov Identifier: NCT00282906     History of Changes
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010