Prostate CancerPhase 1NCT02297386
[18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer
A Phase 1 study testing [18F] DIHYDRO-TESTOSTERONE, PET scan and MRI in people with Prostate Cancer and Localized Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to test the ability of a new PET scan radiotracer, called FDHT (stands for [18F] Dihydro-Testosterone), to better find and monitor prostate cancer. Radiotracers are a type of drug that carries small amounts of radioactivity that can be seen by the PET scanner. Read more about this study
- Who is it for?
- Ages 21 to 79 years, men only
- Conditions the study is for
- Prostate Cancer, Localized Prostate Cancer
- What is being tested?
- [18F] DIHYDRO-TESTOSTERONE, PET scan and MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Aug 2018
- Phase
- 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 21 to 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male aged 21 years or older and below 80 years of age.
- Signed written informed consent and willingness to comply with protocol requirements.
- Histologically confirmed diagnosis of prostate cancer.
- Staging imaging workup including a baseline MRI of the prostate and pelvis performed at MSKCC.
- Baseline imaging to rule out distant metastatic disease (99mTc bone scan, NaF PET, total body MRI, or CT chest/abdomen/pelvis)
- Karnofsky performance status ≥ 70
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- Clinical criteria required to be eligible:
- One of the following i.Pre-treatment PSA ≥10 ng/dL, OR ii. Clinical T-stage assessed by digital rectal exam of ≥T2a, OR ii . Radiographic ≥T3a on MRI, OR iv. Gleason score of ≥3+4=7 c. Visible intraprostatic tumor foci ≥1 cm in largest dimension on T2-weighted images based on initial pre-treatment MRI
- Physician recommendation of ADT.
Who cannot join
- Metastatic disease on standard staging imaging (beyond regional lymph node involvement).
- o Absence of metastatic disease (beyond regional lymph node involvement) as defined by a negative bone scan, NaF PET, CT chest/abdomen/pelvis, or total body MRI.
- Prior treatment of the prostate gland for malignant conditions (surgery, cryotherapy, radiotherapy, or photodynamic therapy).
- Physician prescription of androgen receptor antagonist therapy (examples: bicalutamide, flutamide, or enzalutamide) during time of protocol scans.
- o Note: ADT consists of chemical castration (i.e. degarelix) to remove endogenous DHT. Androgen receptor antagonists will bind to the androgen receptor and inhibit FDHT from binding.
- Patients receiving testosterone supplementation .
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- Any contraindication to baseline MRI based on departmental MR questionnaire, or inability to cooperate for an MRI scan.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to FDHT.
- Hepatic laboratory values:
- Bilirubin >1.5 x ULN (institutional upper limits of normal)
- AST/ALT >2.5 x ULN
- Albumin <2 g/dL
- Creatinine >2.5 mg/dL
- Calcium >11 mg/dL
- Other serious illness(es) which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Phase I Trial Of [18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer
The purpose of this study is to test the ability of a new PET scan radiotracer, called FDHT (stands for [18F] Dihydro-Testosterone), to better find and monitor prostate cancer. Radiotracers are a type of drug that carries small amounts of radioactivity that can be seen by the PET scanner. FDHT is a radiotracer that looks for a protein which is present in almost all prostate cancer cells. The investigators want to find out if we can find and monitor changes in cancer using a FDHT PET scan.
- Conditions
- Prostate Cancer, Localized Prostate Cancer
- Being tested
- [18F] DIHYDRO-TESTOSTERONE, PET scan, MRI, Blood draw
- Keywords
- [18F] Dihydro-testosterone, PET Scan, MRI, 14-185
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F] DIHYDRO-TESTOSTERONEDrug
PET scanDevice
MRIDevice
Blood drawOther
| Study group | Role | What they receive |
|---|---|---|
| [18F] DIHYDRO-TESTOSTERONE PET | Experimental | The diagnostic intervention of this study is the use of FDHT PET in localized prostate cancer. Patients will undergo a 30 minute dynamic scan of the pelvis followed by a whole body scan of approximately 30-minutes duration. The dynamic scan will be optional, but strongly encouraged. PET scanning will preferably be done on the GE Discovery STE PET/CT scanner or the equivalent generation of scanner. The PET scans are routinely "quantitative," that is corrected for attenuation and scatter and adjusted for system sensitivity and providing parametric images in terms of standardized uptake values (SUV) (= μCi found/gm tissue / μCi injected/gm body mass). Receives: Drug: [18F] DIHYDRO-TESTOSTERONE; Device: PET scan; Device: MRI; Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
increase in standardize uptake values (SUV) between the second and third FDHT scans
Enrolling 15 patients will provide 80% power to detect a 33% increase in the mean uptake (from 6 to 8) between the 2nd and the 3rd scans.
Measured: 1 year
Secondary outcomes (1)
correlate AR expression to FDHT uptake
involves collecting formalin fixed paraffin embedded tissue from pre-treatment biopsy specimens to correlate androgen receptor (AR) expression to FDHT uptake. AR expression will be measured using RNA-seq and correlated with FDHT SUV values separately for each scan using Spearman's rank correlation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionAug 2018
- Study completionAug 2018
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 Memorial Sloan Kettering Cancer CenterThe 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
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Osborne, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297386
- Sponsor's protocol ID
- 14-185
- Status last verified
- Aug 2018
- First submitted
- 18 Nov 2014
- Last updated
- 6 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial Of [18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT02297386
- Acronym / sponsor ID
- 14-185
- Conditions
- Prostate Cancer, Localized Prostate Cancer
- Keywords
- [18F] Dihydro-testosterone, PET Scan, MRI, 14-185
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 21 Nov 2014 (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.
The purpose of this study is to test the ability of a new PET scan radiotracer, called FDHT (stands for [18F] Dihydro-Testosterone), to better find and monitor prostate cancer. Radiotracers are a type of drug that carries small amounts of radioactivity that can be seen by the PET scanner. FDHT is a radiotracer that looks for a protein which is present in almost all prostate cancer cells. The investigators want to find out if we can find and monitor changes in cancer using a FDHT PET scan.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F] DIHYDRO-TESTOSTERONE PET | Experimental | Drug: [18F] DIHYDRO-TESTOSTERONE, Device: PET scan, Device: MRI, Other: Blood drawThe diagnostic intervention of this study is the use of FDHT PET in localized prostate cancer. Patients will undergo a 30 minute dynamic scan of the pelvis followed by a whole body scan of approximately 30-minutes duration. The dynamic scan will be optional, but strongly encouraged. PET scanning will preferably be done on the GE Discovery STE PET/CT scanner or the equivalent generation of scanner. The PET scans are routinely "quantitative," that is corrected for attenuation and scatter and adjusted for system sensitivity and providing parametric images in terms of standardized uptake values (SUV) (= μCi found/gm tissue / μCi injected/gm body mass). |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male aged 21 years or older and below 80 years of age.
- Signed written informed consent and willingness to comply with protocol requirements.
- Histologically confirmed diagnosis of prostate cancer.
- Staging imaging workup including a baseline MRI of the prostate and pelvis performed at MSKCC.
- Baseline imaging to rule out distant metastatic disease (99mTc bone scan, NaF PET, total body MRI, or CT chest/abdomen/pelvis)
Key exclusion criteria (15 listed)
- Metastatic disease on standard staging imaging (beyond regional lymph node involvement).
- o Absence of metastatic disease (beyond regional lymph node involvement) as defined by a negative bone scan, NaF PET, CT chest/abdomen/pelvis, or total body MRI.
- Prior treatment of the prostate gland for malignant conditions (surgery, cryotherapy, radiotherapy, or photodynamic therapy).
- Physician prescription of androgen receptor antagonist therapy (examples: bicalutamide, flutamide, or enzalutamide) during time of protocol scans.
- o Note: ADT consists of chemical castration (i.e. degarelix) to remove endogenous DHT. Androgen receptor antagonists will bind to the androgen receptor and inhibit FDHT from binding.
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 |
|---|---|---|
| [18F] DIHYDRO-TESTOSTERONE | Drug | [18F] DIHYDRO-TESTOSTERONE PET |
| PET scan | Device | [18F] DIHYDRO-TESTOSTERONE PET |
| MRI | Device | [18F] DIHYDRO-TESTOSTERONE PET |
| Blood draw | Other | [18F] DIHYDRO-TESTOSTERONE PET |
Primary outcome
increase in standardize uptake values (SUV) between the second and third FDHT scans
Time frame: 1 year
Enrolling 15 patients will provide 80% power to detect a 33% increase in the mean uptake (from 6 to 8) between the 2nd and the 3rd scans.
1 secondary outcome
correlate AR expression to FDHT uptake
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Joseph Osborne, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F] DIHYDRO-TESTOSTERONE, PET scan and MRI in people with Prostate Cancer and Localized Prostate Cancer, run by Memorial Sloan Kettering Cancer Center 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 9 inclusion and 15 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: finished, as of the sponsor's last update on 6 Aug 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
increase in standardize uptake values (SUV) between the second and third FDHT scans (time frame: 1 year). 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 6 Aug 2018.