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Trial record 5 of 278 for:    prostate cancer AND localized | ( Map: United States )

[18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02297386
Recruitment Status : Completed
First Posted : November 21, 2014
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Localized Prostate Cancer Drug: [18F] DIHYDRO-TESTOSTERONE Device: PET scan Device: MRI Other: Blood draw Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase I Trial Of [18F] Dihydro-testosterone Pet and MR Imaging In Patients With Localized Prostate Cancer
Actual Study Start Date : November 2014
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: [18F] DIHYDRO-TESTOSTERONE PET
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).
Drug: [18F] DIHYDRO-TESTOSTERONE
Device: PET scan
Device: MRI
Other: Blood draw



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. correlate AR expression to FDHT uptake [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   21 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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:

    1. Bilirubin >1.5 x ULN (institutional upper limits of normal)
    2. AST/ALT >2.5 x ULN
    3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02297386


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Joseph Osborne, MD, PhD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02297386     History of Changes
Other Study ID Numbers: 14-185
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Keywords provided by Memorial Sloan Kettering Cancer Center:
[18F] Dihydro-testosterone
PET Scan
MRI
14-185
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Dihydrotestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents