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PET Acetate for Docetaxel Response Assessment in Hormone-Refractory Prostate Cancer

Phase 2
18 Years
Open (Enrolling)
Castrate Resistant Prostate Cancer, Prostate Cancer

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Trial Information

PET Acetate for Docetaxel Response Assessment in Hormone-Refractory Prostate Cancer

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

- 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

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

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

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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Interpretation of PET Acetate scans

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

Daniel Vaena, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Iowa


United States: Institutional Review Board

Study ID:




Start Date:

June 2010

Completion Date:

May 2014

Related Keywords:

  • Castrate Resistant Prostate Cancer
  • Prostate Cancer
  • Castrate resistant
  • Prostate cancer
  • Docetaxel
  • Taxotere
  • PET Acetate
  • Prostatic Neoplasms



University of Iowa Hospitals and ClinicsIowa City, Iowa  52242