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View Clinical Trial (Medical Research Study)
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[F-18]-Fluorodeoxyglucose (FDG) Positron Emission Tomography and Computed Tomography (PET-CT) in Metastatic Prostate Cancer - NCT00282906-90033 (Clinical Trial 136753)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy136753.aspx
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| City: |
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Los Angeles |
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State:
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CA |
| Zip Code: |
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90033 |
| Conditions: |
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Prostate Cancer |
| Purpose: |
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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).
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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USC/Norris Comprehensive Cancer Center
Los Angeles, CA 90033
United States
Primary Contact:
Jennifer Encinas
Email: jencinas@usc.edu
Phone: 323-865-3228
Secondary Contact:
Jennifer Encinas
Email: jencinas@usc.edu
Phone: 323/865-3228 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 15, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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