Recruiting

Fluoro-2-Deoxy-D-Glucose & Dihydro-Testosterone

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT00588185

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Prostate Cancer

Study ID

NCT00588185

Start date

Feb, 2003

Status verified date

Sep, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

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

Salivary Gland Cancers

Inclusion Criteria:

  • Histologically proven diagnosis of salivary cancer with AR expression detected by immunohistochemistry
  • Measurable disease as defined by RECIST v1.1 criteria
  • Locally advanced/unresectable (as determined by local surgeon) OR metastatic disease.
  • Age ≥ 18 years
  • ECOG performance status 0 or 1
  • AST/ALT < 3xULN
  • No prior AR-targeted therapy (Exception: AR-targeted therapy administered in the adjuvant setting and with disease recurrence more than 6 months since treatment completion)

Exclusion Criteria:

  • Uncontrolled or untreated brain metastases
  • Class 3 or 4 congestive heart failure
  • Uncontrolled hypertension (systolic BP >170 mmHg or diastolic BP >105 mmHg at screening)
  • Vascular or ischemic event within 6 months of study registration.

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 1

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

Interventions

[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.

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 and Locations

Central contacts

Heiko Schoder, MD

212-639-8001

Michael Morris, MD, PhD

646-422-4469

Locations

Memorial Sloan Kettering Basking Ridge (Consent Only)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Heiko Schoder, MD

212-639-8001

Memorial Sloan Kettering Monmouth (Consent only)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Heiko Schoder, MD

212-639-8001

Memorial Sloan Kettering Bergen (Consent Only)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Heiko Schoder, MD

212-639-8001

Memorial Sloan Kettering Commack (Consent only)

Recruiting

Commack, New York, United States, 11725

Contacts

Heiko Schoder, MD

212-639-8001

Memorial Sloan Kettering Westchester (Consent only)

Recruiting

Harrison, New York, United States, 10604

Contacts

Heiko Schoder, MD

212-639-8001

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Heiko Schoder, MD

212-639-8001

Memorial Sloan Kettering Nassau (Consent Only)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Heiko Schoder, MD

212-639-8001

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Keywords

  • Progressive Prostate Cancer
  • [18F]-Fluoro-2-Deoxy-D-Glucose
  • [18F] Dihydro-Testosterone
  • Pet Imaging
  • Pet scan
  • 00-095

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-09-11. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.