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NCT01724619 · ClinicalTrials.gov registry record · Early Phase 1
Update and Biodistribution of [F-18]FMDHT pET/CT in Normal Healthy Volunteers and Patients With Metastatic Prostate Cancer - A First in Human Subject Study With [F-18] FMDHT
A Early Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 7
- Enrollment target
NCT01724619 is a Early Phase 1 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 7 participants.
The verdict
NCT01724619, a Early Phase 1 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Prostate cancer represents a significant health problem in the United States. This year 179,000 men in the United States will be diagnosed with prostate carcinoma and approximately 25% of them will die of the disease. In addition, the incidence and mortality of prostate carcinoma has been increasing steadily in the United States. Prostate-specific antigen (PSA) levels are commonly used as a biomarker for the detection of prostate cancer. Nonetheless, there is a significant false negative and false positive diagnosis since PSA levels elevate in benign prostatic hyperplasia and prostatitis and decrease in patients taking medications and herbal remedies. Twenty percent of biopsy-proven prostate carcinoma have PSA levels within the normal range, thus confounding the diagnosis based on the PSA screening test. Current diagnostic methods that include transrectal ultrasound (TRUS) and TRUS guided prostate biopsy are logistically difficult and insensitive. These are further complicated by equivocal prostatic biopsy findings such as prostatic intraepithelial neoplasia (PIN) or normal PSA with high clinical suspicion. A tracer with high specificity to prostate cancer related structures at a cellular level would enhance our understanding of the pathophysiology of prostate cancer and would contribute to the detection, localization and quantification of the disease and its metastases. This information will be invaluable in selecting the appropriate treatment regimen. This study will test the utility of \[F-18\]FMDHT to image prostate cancer and will evaluate if this radiotracer can differentiate primary prostate cancer in the prostate gland from normal prostate gland itself. More specifically, we will study the distribution kinetics of \[F-18\]FMDHT in normal healthy humans and in patients with prostate cancer. As per exploratory IND requirements, we performed toxicity assessment of FMDHT through an outside laboratory (ILS, Inc.) and the results of that study are attached as Ap
Interventions
- DRUG [F-18] fluorinated dihydrotestosterone (FDHT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2012-11 |
| Est. Completion | 2013-03 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01724619
The ClinicalTrials.gov registry entry for NCT01724619 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which [F-18] fluorinated dihydrotestosterone (FDHT) is the first listed.
NCT01724619 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01724619 about?
NCT01724619 is a clinical study titled "Update and Biodistribution of [F-18]FMDHT pET/CT in Normal Healthy Volunteers and Patients With Metastatic Prostate Cancer - A First in Human Subject Study With [F-18] FMDHT". Prostate cancer represents a significant health problem in the United States. This year 179,000 men in the United States will be diagnosed with prostate carcinoma and approximately 25% of them will die of the disease. In addition, the incidence and mortality of prostate carcinoma has been increasing...
What is the current status of trial NCT01724619?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 7 participants. The study started on 2012-11. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01724619?
The interventions under investigation include: [F-18] fluorinated dihydrotestosterone (FDHT) (DRUG).
Who is sponsoring clinical trial NCT01724619?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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