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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00588185
Status
Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone — DRUG
    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 Details

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.

Key Dates

Start date
Feb 28, 2003
Status verified
Apr 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 1
    \[18F\]-Fluoro-2-Deoxy-D-Glucose and -\[18F\] Dihydro-Testosterone

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 ]

Central Contacts

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

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Consent Only)Basking RidgeNew Jersey07920
Michael Morris, MD
646-422-4469
Memorial Sloan Kettering Monmouth (Consent only)MiddletownNew Jersey07748
Michael Morris, MD
646-422-4469
Memorial Sloan Kettering Bergen (Consent Only)MontvaleNew Jersey07645
Michael Morris, MD
646-422-4469
Memorial Sloan Kettering Commack (Consent only)CommackNew York11725
Michael Morris, MD
646-422-4469
Memorial Sloan Kettering Westchester (Consent only)HarrisonNew York10604
Michael Morris, MD
646-422-4469
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Michael Morris, M.D., Ph,D.
646-422-4469
Michael Morris, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Nassau (Consent Only)UniondaleNew York11553
Michael Morris, MD
646-422-4469

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