Prostate CancerEarly Phase 1NCT01724619
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 testing [F-18] fluorinated dihydrotestosterone (FDHT) in people with Prostate Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- [F-18] fluorinated dihydrotestosterone (FDHT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Mar 2013
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal Healthy Volunteers
- Males age 30 years or older.
- No prior history of cancer.
- Willing to get a PSA evaluated. Normal subjects will be eligible if their PSA is in the normal range for the particular lab where it is drawn. PSA drawn within 6 months (before) of the FMDHT PET scan will be accepted.
- Ability to tolerate PET imaging.
- Ability to understand and willingness to sign a written informed consent document.
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- Prostate Cancer Patients:
- Patients with histologically confirmed adenocarcinoma of the prostate.
- Patients with a clinical staging CT at the time of the first [F-18]FMDHT scan.
- Patients with at least one single focus of metastatic disease (bone/lymph node or soft tissue) confirmed on other clinical studies, preferably biopsy.
- Patients with prior transurethral resection of the prostate are eligible.
- Ability to tolerate PET imaging.
- Males age 30 years or older.
- Ability to understand and willingness to sign a written informed consent document.
- Willing to get a PSA evaluated.
Who cannot join
- Normal Health Volunteers
- Prior diagnosis of any cancer (except non-melanoma skin cancer).
- Prostate Cancer Patients
- Prior diagnosis of cancer except non-melanoma skin cancer.
- Prior treatment (other than biopsy) for prostate cancer.
- Received radiation therapy, hormonal therapy, surgery or cryotherapy for prostate disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
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.
Read more
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 Appendix A.
Based on our and others data, we hypothesize that:
- [F-18]FMDHT PET/CT will distribute initially in various normal tissues following blood flow pattern and will clear rapidly from tissues with no AR.
- [F-18]FMDHT PET/CT will detect metastatic disease that expresses AR.
- [F-18]FMDHT PET/CT uptake will be elevated in AR-expressing prostate cancer lesions compared to surrounding normal prostate.
In order to progress [F-18]FMDHT into clinic, we are performing a pilot 'first-in-human' biodistribution study in subjects with and without prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- [F-18] fluorinated dihydrotestosterone (FDHT)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[F-18] fluorinated dihydrotestosterone (FDHT)Drug
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | F-18] fluorinated dihydrotestosterone (FDHT) PET/CT Receives: Drug: [F-18] fluorinated dihydrotestosterone (FDHT) |
| Prostate Cancer Patients | Experimental | F-18] fluorinated dihydrotestosterone (FDHT) PET/CT Receives: Drug: [F-18] fluorinated dihydrotestosterone (FDHT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To map diffusion and clearance rates of this marker in normal and cancerous tissue.
To obtain first-in-man biodistribution data for [F-18]FMDHT with PET/CT imaging in subjects with and without prostate cancer. The results of these tests will be in the form of scans. Distinguishing characteristics will be how quickly the marker clears from the tissues in the scans.
Measured: Day 1
Secondary outcomes (1)
To determine if [F-18]FMDHT PET/CT uptake in the primary prostate tumor can be differentiated from normal surrounding prostate that will be confirmed with pathologic staining of biopsy or surgical specimens.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Study tracer can no longer be obtained at our institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pradeep Garg, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724619
- Sponsor's protocol ID
- IRB00015971
- Other IDs
- CCCWFU 85111
- Status last verified
- Jul 2018
- First submitted
- 5 Nov 2012
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01724619
- Acronym / sponsor ID
- IRB00015971
- Conditions
- Prostate Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study tracer can no longer be obtained at our institution
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Appendix A.
Based on our and others data, we hypothesize that:
- [F-18]FMDHT PET/CT will distribute initially in various normal tissues following blood flow pattern and will clear rapidly from tissues with no AR.
- [F-18]FMDHT PET/CT will detect metastatic disease that expresses AR.
- [F-18]FMDHT PET/CT uptake will be elevated in AR-expressing prostate cancer lesions compared to surrounding normal prostate.
In order to progress [F-18]FMDHT into clinic, we are performing a pilot 'first-in-human' biodistribution study in subjects with and without prostate cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Drug: [F-18] fluorinated dihydrotestosterone (FDHT)F-18] fluorinated dihydrotestosterone (FDHT) PET/CT |
| Prostate Cancer Patients | Experimental | Drug: [F-18] fluorinated dihydrotestosterone (FDHT)F-18] fluorinated dihydrotestosterone (FDHT) PET/CT |
Who may qualify
- Ages
- 30 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Normal Healthy Volunteers
- Males age 30 years or older.
- No prior history of cancer.
- Willing to get a PSA evaluated. Normal subjects will be eligible if their PSA is in the normal range for the particular lab where it is drawn. PSA drawn within 6 months (before) of the FMDHT PET scan will be accepted.
- Ability to tolerate PET imaging.
Key exclusion criteria (6 listed)
- Normal Health Volunteers
- Prior diagnosis of any cancer (except non-melanoma skin cancer).
- Prostate Cancer Patients
- Prior diagnosis of cancer except non-melanoma skin cancer.
- Prior treatment (other than biopsy) for prostate cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [F-18] fluorinated dihydrotestosterone (FDHT) | Drug | Healthy Volunteers, Prostate Cancer Patients |
Primary outcome
To map diffusion and clearance rates of this marker in normal and cancerous tissue.
Time frame: Day 1
To obtain first-in-man biodistribution data for [F-18]FMDHT with PET/CT imaging in subjects with and without prostate cancer. The results of these tests will be in the form of scans. Distinguishing characteristics will be how quickly the marker clears from the tissues in the scans.
1 secondary outcome
To determine if [F-18]FMDHT PET/CT uptake in the primary prostate tumor can be differentiated from normal surrounding prostate that will be confirmed with pathologic staining of biopsy or surgical specimens.
Time frame: Day 1
Results and safety
The study was stopped early (reason given: Study tracer can no longer be obtained at our institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pradeep Garg, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [F-18] fluorinated dihydrotestosterone (FDHT) in people with Prostate Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study tracer can no longer be obtained at our institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To map diffusion and clearance rates of this marker in normal and cancerous tissue. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.