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

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ClinicalTrials.gov Identifier: NCT00588185
Recruitment Status : Recruiting
First Posted : January 8, 2008
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE December 26, 2007
First Posted Date  ICMJE January 8, 2008
Last Update Posted Date March 13, 2020
Actual Study Start Date  ICMJE February 2003
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2014)
  • The kinetics, metabolism, and biodistribution will be assessed. [ Time Frame: Baseline. 4 weeks and 12 weeks ]
  • To correlate the accumulation of 18FDHT to 18FDG. [ Time Frame: 2 years ]
  • 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 ]
  • relationship between FDHT uptake and tumor diffusivity [ Time Frame: 2 years ]
    assessed by MRI.
  • relationship between FDHT uptake and tissue analyses [ Time Frame: 2 years ]
    of AR expression
Original Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2008)
The kinetics, metabolism, and biodistribution will be assessed. [ Time Frame: Baseline. 4 weeks and 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer
Official Title  ICMJE [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: 1
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone
Intervention: Drug: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 16, 2013)
300
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2008)
55
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael Morris, M.D., PH.D. 646-422-4469
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00588185
Other Study ID Numbers  ICMJE 00-095
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Morris, M.D., Ph.D. Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date March 2020

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