Clinical trial · Interventional
[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
NCT00588185CI-TRIAL-00107771recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- \[18F\]-Fluoro-2-Deoxy-D-Glucose and -\[18F\] Dihydro-Testosterone
- interventionNames
- Drug: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone
Primary outcomes (1)
- 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.
- timeFrame
- Baseline, 4 weeks and 12 weeks
Secondary outcomes (5)
- measure
- The kinetics, metabolism, and biodistribution will be assessed.
- timeFrame
- Baseline. 4 weeks and 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.