Status:
COMPLETED
[18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Prostate Cancer
Localized Prostate Cancer
Eligibility:
MALE
21-79 years
Phase:
PHASE1
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 ty...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02297386
Start Date
November 1 2014
End Date
August 1 2018
Last Update
August 6 2018
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065