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FDG Positron Emission Tomography and Computed Tomography (PET-CT) in Metastatic Prostate Cancer | Clinical Trials | Clareo Health

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

[F-18]-Fluorodeoxyglucose (FDG) Positron Emission Tomography and Computed Tomography (PET-CT) in Metastatic Prostate Cancer

NCT00282906•University of Southern California

View on ClinicalTrials.gov

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).

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

Age

21 - No limit years

Sex

MALE

Healthy Volunteers

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 received prior to the development of objective evidence for MACRO metastatic or recurrent disease (e.g. during biochemical PSA relapse without imaging evidence of disease).
•Evidence of metastatic disease must be documented as: conventional imaging evidence for metastatic disease as determined by CT, bone scintigraphy, or both (Note: although there are no strict windows for obtaining other scans bone, CT) relative to the timing of the PET scans, every effort will be made to have these 'standard' scans obtained within 3 months of the Baseline PET scan
•Age \> 21 years, men of all ethnic backgrounds
•Patients must have received prior hormonal therapy. Patients treated with orchiectomy are eligible.
•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. Evidence of unresponsive or refractory disease must be documented by either:
•1. a progression of disease assessed with CT or bone scan or as judged clinically based on factors such as increasing bone pain (Note: although there are no strict windows for obtaining other scans (bone, CT) relative to the timing of the PET scans, every effort will be made to have these 'standard' scans obtained within 3 months of the PET scan) OR
•2. a rising serum PSA level - defined as at least 2 consecutive rises in PSA documented over a reference value (1st measure within 3 months 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) should be obtained at least 14 days after the 2nd measure 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. However, if the patient is clinically judged to have progressive disease irrespective of PSA (e.g. metastasis-related bone pain, clear increase in lesions evident on a bone scan and/or CT if available), documenting a minimum or rising PSA level would not be required.
•If the treating physician has determined that the patient is not clinically responding to the current therapy prescribed and, in the best interest of the patient, the physician plans to change the treatment to a new treatment.
•1. Example: a Group I patient currently treated with a form of anti-androgen therapy which is not responding; the patient can be considered for enrollment into the PET-CT imaging study prior to a new anti-androgen therapy even though he was treated with anti-androgen therapy before. The wait time between the end of old therapy and the beginning of the new therapy is based entirely on clinical judgment
+7 more criteria

Exclusion Criteria

•History of cancer other than prostate cancer (except squamous cell carcinoma of the skin that has been treated with curative intent) or other cancers clinically judged to be cured or inactive based on history, physical examination, tumor markers, or imaging findings.
•Active infection (except mild upper respiratory infections or other sites if clinically judged not to interfere with image interpretation on a per case basis)
•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

Locations (1)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Key Dates

Start Date

October 3, 2005

Primary Completion Date

December 19, 2013

Completion Date

August 19, 2014

Last Updated

April 18, 2017

Enrollment

257

ACTUAL participants

Conditions

Prostate Cancer

Interventions

hybrid PET-CT imaging system

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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