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

Clinicaltrials.gov ID: NCT00588185
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age All Ages
b-bullseye-arrow Enrollments 300

Conditions

Prostate Cancer

Drugs

[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone

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.

Locations

7 locations Found with status Recruiting

Status

  • RECRUITING

Contact Person

  • Michael Morris, MD
  • 646-422-4469

Principal Investigator

  • Michael Morris, M.D., Ph.D.

Status

  • RECRUITING

Contact Person

  • Michael Morris, MD
  • 646-422-4469

Principal Investigator

  • Michael Morris, M.D., Ph.D.

Status

  • RECRUITING

Contact Person

  • Michael Morris, MD
  • 646-422-4469

Principal Investigator

  • Michael Morris, M.D., Ph.D.

Status

  • RECRUITING

Contact Person

  • Michael Morris, MD
  • 646-422-4469

Principal Investigator

  • Michael Morris, M.D., Ph.D.

Status

  • RECRUITING

Contact Person

  • Michael Morris, MD
  • 646-422-4469

Principal Investigator

  • Michael Morris, M.D., Ph.D.

Status

  • RECRUITING

Contact Person

  • Michael Morris, M.D., Ph,D.
  • 646-422-4469

Principal Investigator

  • Michael Morris, M.D., Ph.D.

Status

  • RECRUITING

Contact Person

  • Michael Morris, MD
  • 646-422-4469

Principal Investigator

  • Michael Morris, M.D., Ph.D.

Eligibility Criteria

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

relationship between FDHT uptake and tissue analyses

Time Frame: 2 years

Timeline

  • Last Updated
    March 21, 2024
  • Start Date
    January 8, 2008
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    February 1, 2026

Similar Trials

light-list-check RECRUITING light-blue-people 21 - 64 Years
light-list-check RECRUITING light-blue-people ≥ 18 Years
light-list-check RECRUITING light-blue-people ≥ 65 Years