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One purpose of this research study is to examine if a special type of imaging test, a positron emission tomography (PET) scan using the radioactive material [C-11] acetate, will be helpful in detecting prostate cancer lesions in subjects with castrate-resistant prostate cancer (CRPC). This PET scan will be combined with a computed tomography (CT) scan taken during the same imaging session. The other purpose of the PET-CT scan using [C-11] acetate (PET Acetate Scan) is to assist in identifying who is responding to the treatment (docetaxel chemotherapy).
The purpose of the current pilot clinical trial is to attempt to identify the safety and accuracy of PET-acetate imaging in the assessment of response of persons undergoing first-line docetaxel for CRPC. If successful, the current research could lead to the incorporation of PET-acetate into future study protocols where continuation of chemotherapy is based on early PET-acetate results, provided that effective second-line therapy options are available (which is an expectation for the near future, based on several ongoing and presented phase III trials).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET Acetate Imaging with Docetaxel | Experimental | PET-acetate as an intermediate endpoint in the assessment of response of patients undergoing docetaxel for hormone refractory prostate cancer (HRPC). Subjects will be treated with docetaxel, 75 mg/m2 every 21 days until disease progression or unacceptable toxicity occurs. Subjects will have two PET acetate scans - one prior to beginning chemotherapy and one approximately 8-9 weeks after chemotherapy has begun. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET Acetate scan | Radiation | PET Acetate scans will be done to detect prostate cancer lesions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Interpretation of PET Acetate scans | Standardized uptake values (mean and maximum SUVs) will be determined over the prostate bed and over any acetate-avid or CT-identified suspicious lesions. The change in these SUVs with treatment will be assessed, as well as the number of lesions. A blinded second reviewer from Nuclear Medicine will reviewed all baseline and response PET-acetate scans. | Time of enrollment up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Prostate cancer response to treatment and progression (excluding PET Acetate assessment) | Correlation with chemotherapy response | Time of enrollment up to two years |
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Inclusion Criteria:
Ability to understand and willingness to sign a written consent document.
Patients must have histologically documented adenocarcinoma of the prostate at any time in the past.
At the time of enrollment: Patients must have evidence of castrate resistant metastatic prostate cancer (patients with rising PSA only and no other radiographic evidence of metastatic prostate cancer are not eligible). In addition, progressive disease is required as per #5 below.
Two categories of eligible patients exist: Measurable disease with any level of serum prostate-specific antigen (PSA) OR Non-measurable disease (positive bone scan) with PSA equal or greater than 2 ng/ml
Definition of Measurable Disease/Target Lesions - Any lesion >/= 1 cm on spiral computed tomography (CT) that is believed to represent metastatic prostate cancer and that can be accurately measured in at least one dimension (longest diameter). However, if the lesion is a lymph node, it needs to be equal or greater than 20 mm (longest diameter) based on CT scans or physical exam (palpable lymph nodes). Chest X-ray with clearly defined lung lesions surrounded by aerated lung or parenchymal lung lesions measured as 10 mm or greater with a spiral CT are also eligible.
Definition of Non-measurable Disease/Non-target Lesions - Non-target lesions include all other lesions not included above, including bone lesions. Previously irradiated lesions should not be used for eligibility unless progression was documented after radiation therapy.
In order to be eligible, patients must have demonstrated evidence of progressive disease prior to enrollment. Progressive disease is defined as any one of the following:
Progression despite standard androgen deprivation therapy.
At least 4 weeks since any systemic steroids (any dose; unless used chronically for another illness at equal or less than 10 mg of prednisone daily, or in conjunction with prior ketoconazole resulting in slow steroid taper) and any other hormonal therapy.
No prior cytotoxic chemotherapy for prostate cancer.
Four weeks or longer since major surgery and fully recovered.
Four weeks or longer since any prior radiation (including palliative) and fully recovered.
No prior strontium or samarium.
Concurrent bisphosphonate use is allowed. However, if patient has not previously been on bisphosphonate, first dose should only occur after the baseline positron emission tomography (PET) acetate scan has been obtained.
ECOG performance status: 0-2
Age ≥ 18
Required Initial Laboratory Values (within 14 days of registration):
ANC ≥1500/microL; Platelet count ≥ 100,000/microL; Creatinine ≤1.5 x upper limits of normal; Bilirubin ≤ 1.5 x upper limits of normal; AST and ALT ≤ 1.5 x upper limits of normal; PSA level requirements: see #4; Serum Testosterone ≤ 50 ng/ dL (for patients who have not had bilateral orchiectomy); Estimated glomerular filtration rate > 30 mL/min
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Vaena, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C438206 | carbon-11 acetate |
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| Carbon-11 labeled Acetate | Drug | C-11 Acetate is a radiotracer used in PET scanning |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |