Back to results[18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer
Primary Purpose
Prostate Cancer, Localized Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[18F] DIHYDRO-TESTOSTERONE
PET scan
MRI
Blood draw
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring [18F] Dihydro-testosterone, PET Scan, MRI, 14-185
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[18F] DIHYDRO-TESTOSTERONE PET
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02297386
First Posted
November 18, 2014
Last Updated
August 3, 2018
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02297386
Brief Title
[18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer
Official Title
Phase I Trial Of [18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Localized Prostate Cancer
Keywords
[18F] Dihydro-testosterone, PET Scan, MRI, 14-185
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[18F] DIHYDRO-TESTOSTERONE PET
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
[18F] DIHYDRO-TESTOSTERONE
Intervention Type
Device
Intervention Name(s)
PET scan
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Type
Other
Intervention Name(s)
Blood draw
Primary Outcome Measure Information:
Title
increase in standardize uptake values (SUV) between the second and third FDHT scans
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
correlate AR expression to FDHT uptake
Description
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.
Time Frame
1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Osborne, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
[18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer
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