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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses PET scans with radioactive tracers called FDG and FDHT. It looks at whether these scans can better find where prostate cancer has spread. People with certain prostate cancers or salivary gland cancers may join.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Prostate cancer: A tissue test must confirm the cancer, and cancer spots must show on CT, MRI, or bone scans.
  • Prostate cancer: Scans must show new or growing cancer, OR PSA blood levels must rise. This means at least 3 rising PSA results at least 1 week apart, or 2 results at least 2 weeks apart.
  • Prostate cancer: You must give informed consent, meaning you understand the study and agree to join.
  • Salivary gland cancer: A tissue test must confirm the cancer and show androgen receptors (AR), proteins that respond to male hormones.
  • Salivary gland cancer: The cancer must be measurable by study rules. It must have spread far away, or be advanced nearby and not removable by surgery.
  • Salivary gland cancer: You must be at least 18 and able to do all usual activities or only have limits on hard physical activity.
  • Salivary gland cancer: Liver blood tests called AST and ALT must be below 3 times the upper normal limit.
  • Salivary gland cancer: You must not have had treatment aimed at AR. An exception allows this treatment if it was given after the main treatment and the cancer returned more than 6 months after it ended.

Who can't join

  • Prostate cancer: A past severe allergic reaction called anaphylaxis to FDHT or FDG.
  • Prostate cancer: Liver test results outside these limits: bilirubin above 1.5 times the upper normal limit, AST/ALT above 2.5 times that limit, or albumin below 2 g/dL. GGT above 2.5 times the upper normal limit also applies if alkaline phosphatase is above 2.5 times that limit.
  • Prostate cancer: Kidney tests showing creatinine above 1.5 times the upper normal limit or creatinine clearance, a measure of kidney filtering, below 60 mL/min.
  • Salivary gland cancer: Cancer that has spread to the brain and is untreated or not controlled.
  • Salivary gland cancer: Class 3 or 4 heart failure, meaning serious trouble with the heart's pumping.
  • Salivary gland cancer: Uncontrolled high blood pressure at screening, with a top number above 170 or a bottom number above 105.
  • Salivary gland cancer: A blood vessel problem or an event caused by too little blood flow within 6 months before signing up.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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 sites (7)

NJ

NY