[18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer
Phase I Trial Of [18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer
1 other identifier
interventional
3
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 prostate-cancer
Started Nov 2014
Typical duration for phase_1 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 18, 2014
CompletedFirst Posted
Study publicly available on registry
November 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedAugust 6, 2018
August 1, 2018
3.8 years
November 18, 2014
August 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 year
Secondary Outcomes (1)
correlate AR expression to FDHT uptake
1 year
Study Arms (1)
[18F] DIHYDRO-TESTOSTERONE PET
EXPERIMENTALThe 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).
Interventions
Eligibility Criteria
You may qualify if:
- 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
- Clinical criteria required to be eligible:
- a. 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.
You may not qualify if:
- 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 .
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Osborne, MD, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2014
First Posted
November 21, 2014
Study Start
November 1, 2014
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
August 6, 2018
Record last verified: 2018-08