PET Acetate for Castrate-Resistant Prostate Cancer on 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).

Inclusion Criteria:

1. Ability to understand and willingness to sign a written consent document.

2. Patients must have histologically documented adenocarcinoma of the prostate at any
time in the past.

3. 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.

4. 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.

5. 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:

- Measurable Disease Progression: Objective evidence of increase 20% or more in the
sum of the longest diameters (LD) of target lesions from the time of maximal
regression after prior therapy; or the appearance of one or more new lesions.

- Bone Scan Progression: Appearance of two or more new lesions on bone scan. If no
prior bone scan exists, presence of 2 lesions is needed for eligibility.

- PSA Progression: An elevated PSA (2 ng/mL or higher) which has risen serially on
at least two occasions at least each 1 week apart. Note: If patient was on
antiandrogens as last therapy, 6 weeks need to elapse after discontinuation of
the antiandrogen. For prior ketoconazole, 4 weeks need to elapse. If the
confirmatory PSA (#2) value is less than the first rising PSA value, then an
additional rising PSA (#3) will be required to document progression. For the
purposes of this study, the last PSA value recorded prior to the initiation of
treatment will be considered the baseline PSA.

6. Progression despite standard androgen deprivation therapy.

7. 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.

8. No prior cytotoxic chemotherapy for prostate cancer.

9. Four weeks or longer since major surgery and fully recovered.

10. Four weeks or longer since any prior radiation (including palliative) and fully
recovered.

11. No prior strontium or samarium.

12. 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.

13. ECOG performance status: 0-2

14. Age ≥ 18

15. 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:

1. No known brain metastases (brain imaging MRI/CT is not required unless clinical
symptoms).

2. No current congestive heart failure (New York Heart Association Class III or IV).

3. No serious or non-healing wound, ulcer or bone fracture.

4. No peripheral neuropathy ≥ grade 2.

5. Patients with known hypersensitivity to Chinese hamster ovary cell products or other
recombinant human antibodies are not eligible.

6. Patients who received prior docetaxel for any reason are not eligible.

7. PC-Spes, Saw Palmetto, and St. John's Wort must be discontinued before registration.
The discontinuation of other herbal medications and food supplements is strongly
encouraged. Patients may continue on daily vitamins and calcium supplements.

8. No known allergy to acetate.

9. No severe claustrophobia

10. Concurrent use of statins is allowed on study but use should not have started 30 days
prior to entry into the study