[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00588185
First received: December 26, 2007
Last updated: April 21, 2014
Last verified: April 2014

December 26, 2007
April 21, 2014
February 2003
February 2015   (final data collection date for primary outcome measure)
To study the accumulation and biodistribution of FDHT in patients with progressive prostate cancer. The accumulation and location of FDHT activity will be assessed on a site by site basis and correlated with radionuclide bone scan, CT and MRI. [ Time Frame: Baseline, 4 weeks and 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00588185 on ClinicalTrials.gov Archive Site
  • The kinetics, metabolism, and biodistribution will be assessed. [ Time Frame: Baseline. 4 weeks and 12 weeks ] [ Designated as safety issue: No ]
  • To correlate the accumulation of 18FDHT to 18FDG. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To study changes in 18FDHT accumulation over time in patients treated with: Castration and other hormones, Chemotherapy, Agents directed toward the androgen receptor [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • relationship between FDHT uptake and tumor diffusivity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    assessed by MRI.
  • relationship between FDHT uptake and tissue analyses [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    of AR expression
The kinetics, metabolism, and biodistribution will be assessed. [ Time Frame: Baseline. 4 weeks and 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer

This study will use PET scans, which is a type of x-ray test that uses a radiotracer, to see whether these scans may be better able to find places in the body where your prostate cancer may have spread.

Our preliminary studies have shown that whole body FDG-PET imaging identifies areas of abnormal metabolism in a majority of tumor sites in patients with progressive disease and that changes in FDG accumulation parallel changes in PSA after treatment. This suggests that changes in FDG metabolism may provide an early assessment of treatment outcomes. In previous work we established a methodology to examine a radiotracer in patients with progressive disease and abnormal imaging studies, which we have applied to the clinical states of non-castrate and castrate metastatic disease. This design is characterized by:

1) Evaluation of uptake on a site-by-site basis in relation to conventional studies 2) Standardization of uptake values in tumor relative to a normal organ 3) Controlling for progression using standard measures of progression including a rising PSA, new or enlarging lesions on bone or transaxial imaging, and new symptoms of disease. In the present study we are evaluating fluorinated dihydrotestosterone (FDHT) in addition to FDG. FDHT is targeted to the AR and has been shown in preliminary studies to visualize prostate cancers in man. This study will apply our established methods to investigate FDHT imaging in patients with progressive prostate cancer. In the selected cases where tumor is available, we will study associations between FDHT accumulation and AR expression.

Interventional
Not Provided
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Prostate Cancer
Drug: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone
Registered patients will undergo PET scanning using either FDHT alone or FDG and FDHT depending on the clinical question being asked. Scans will be performed serially at baseline, week 4, week 12, and every 12 weeks of treatment up to a maximum of 8 FDHT/FDG scan set in a 12 month period (maximum 40 scan sets per lifetime) unless the therapeutic protocol or scientific rationale of the therapeutic drug being applied specifically dictates an alternative schedule. Patients may have blood drawn for the purposes of establishing the pharmacokinetics of FDHT and may also undergo an initial dynamic scan if further pharmacokinetic information is warranted, followed by a standard whole body image. If no further pharmacokinetic information is warranted, then patients will only undergo a standard whole body image.
Experimental: 1
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone
Intervention: Drug: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
February 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with histologically confirmed prostate cancer.
  • Progressive disease manifest by either:
  • Imaging modalities:
  • Bone Imaging: New osseous lesions on bone imaging (bone scintigraphy or NaF PET scan) and/or MRI or CT: An increase in measurable soft tissue disease, or the appearance of new sites of disease. Or
  • Biochemical progression: A minimum of three rising PSA values from a baseline that are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart.
  • Visible lesions by either CT, bone imaging, or MRI consistent with disease.
  • Informed consent.

Exclusion Criteria:

  • Previous anaphylactic reaction to either FDHT or FDG
  • Hepatic: Bilirubin > 1.5 x upper limit of normal (ULN), AST/ALT >2.5 x ULN, albumin < 2 g/dl, and GGT > 2.5 x ULN IF Alkaline phosphatase > 2.5 x ULN
  • Renal: Creatinine >1.5 x ULN or creatinine clearance < 60 mL/min
Male
Not Provided
No
Contact: Michael Morris, M.D., PH.D. 646-422-4469
United States
 
NCT00588185
00-095
Yes
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Michael Morris, M.D., Ph.D. Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
April 2014

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