Actively Recruiting

Phase Not Applicable
MALE
ID00588185

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

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-09

300

Participants Needed

7

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the use of PET scans with two different radiotracers, FDG and FDHT, in men with progressive prostate cancer. The study focuses on whether these scans can better detect areas where the cancer may have spread in the body. It builds on earlier findings that changes in FDG uptake relate to cancer progression and treatment response, and now investigates FDHT, which targets the androgen receptor in prostate cancer. Participants will undergo PET scans using FDHT alone or both FDG and FDHT based on clinical questions. Scans will take place at baseline, 4 weeks, 12 weeks, and then every 12 weeks for up to one year, with a maximum of 8 scan sets per year and 40 over a lifetime unless otherwise directed. Some patients may have blood draws to study how FDHT moves through the body and may have an initial dynamic scan followed by a standard whole-body PET scan. During the study, researchers will assess where and how much FDHT accumulates in tumors, comparing these findings with other imaging like bone scans, CT, and MRI at baseline, 4 weeks, and 12 weeks. They will also monitor kinetics and metabolism of the tracer, changes over time, and correlations with disease markers and tissue analyses. The study involves repeated imaging and blood tests to better understand prostate cancer progression and response to treatment.

CONDITIONS

Brief Title

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

Who Can Participate

MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with histologically confirmed prostate cancer
  • Evidence of progressive disease shown by new or enlarging lesions on bone imaging, CT, or MRI, or rising PSA levels with specific measurement criteria
  • Visible lesions consistent with disease on CT, bone imaging, or MRI
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Previous severe allergic reaction to FDHT or FDG
  • Liver function abnormalities: bilirubin greater than 1.5 times upper limit of normal, AST/ALT greater than 2.5 times upper limit of normal, albumin less than 2 g/dl, or GGT greater than 2.5 times upper limit of normal if alkaline phosphatase is above 2.5 times upper limit of normal
  • Kidney function abnormalities: creatinine greater than 1.5 times upper limit of normal or creatinine clearance below 60 mL/min

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 12 months

Participants undergo PET scanning using FDHT and/or FDG to evaluate the accumulation and distribution of these tracers in relation to prostate cancer progression.

Baseline scan, scans at week 4, week 12, and every 12 weeks thereafter up to a maximum of 8 scan sets within 12 months

Long-term Monitoring

Duration - Up to 2 years

Participants are monitored for changes in tracer accumulation and disease progression over time, with assessments continuing up to 2 years.

Periodic imaging and assessments as scheduled by the study

Trial Site Locations

Total: 7 locations

1

Memorial Sloan Kettering Basking Ridge (Consent Only)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

2

Memorial Sloan Kettering Monmouth (Consent only)

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

Memorial Sloan Kettering Commack (Consent only)

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, United States, 10604

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

7

Memorial Sloan Kettering Nassau (Consent Only)

Uniondale, New York, United States, 11553

Actively Recruiting

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Research Team

M

Michael Morris, M.D., PH.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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