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PET Acetate for Castrate-Resistant Prostate Cancer on Chemotherapy

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ClinicalTrials.gov Identifier: NCT01144897
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Daniel Vaena, University of Iowa

June 14, 2010
June 16, 2010
October 2, 2018
May 2010
November 2011   (Final data collection date for primary outcome measure)
Interpretation of PET Acetate scans [ Time Frame: Time of enrollment up to one year ]
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.
Interpretation of PET Acetate scans [ Time Frame: One year ]
Complete list of historical versions of study NCT01144897 on ClinicalTrials.gov Archive Site
Prostate cancer response to treatment and progression (excluding PET Acetate assessment) [ Time Frame: Time of enrollment up to two years ]
Correlation with chemotherapy response
Prostate cancer response to treatment and progression (excluding PET Acetate assessment) [ Time Frame: 2-3 years ]
Correlation with chemotherapy response.
Not Provided
Not Provided
 
PET Acetate for Castrate-Resistant Prostate Cancer on Chemotherapy
PET Acetate for Docetaxel Response Assessment in Hormone-Refractory Prostate Cancer
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).
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Castrate Resistant Prostate Cancer
  • Prostate Cancer
  • Radiation: PET Acetate scan
    PET Acetate scans will be done to detect prostate cancer lesions.
  • Drug: Carbon-11 labeled Acetate
    C-11 Acetate is a radiotracer used in PET scanning
    Other Name: C-11 Acetate; Acetate
Experimental: PET Acetate Imaging with Docetaxel

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.

Interventions:
  • Radiation: PET Acetate scan
  • Drug: Carbon-11 labeled Acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
20
September 2018
November 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01144897
201002720
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: No
Daniel Vaena, University of Iowa
Daniel Vaena
Not Provided
Principal Investigator: Daniel Vaena, MD University of Iowa
University of Iowa
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP