Trial record 21 of 334 for:    Expanded Access Studies

Detecting Recurrent Prostate Cancer With 11C-choline Positron Emission Tomography

Expanded access is currently available for this treatment.
Verified August 2015 by Memorial Sloan Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02531672
First received: August 20, 2015
Last updated: NA
Last verified: August 2015
History: No changes posted
  Purpose
The purpose of this study is to use a new imaging drug called 11C-choline that is used with a PET/CT scan to see prostate cancer when it cannot be seen well on other scans, such as bone scans, CT or MRI.

Condition Intervention
Prostate Cancer
Recurrent Prostate Cancer
Drug: 11C-choline
Device: PET/CT Scan

Study Type: Expanded Access     What is Expanded Access?
Official Title: Detecting Recurrent Prostate Cancer With 11C-choline Positron Emission Tomography: An Expanded Access Study

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Study Start Date: August 2015
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must have biopsy-proven adenocarcinoma of the prostate initially treated with curative intent (surgery and radiation therapy are most common treatments but other treatments are also eligible).
  • Biochemical recurrence defined as any of the following:

    1. PSA ≥ 0.2 ng/mL in at least two sequential tests for patients treated with surgery.
    2. PSA ≥ 2.0 ng/mL above the post therapy nadir for patients treated with radiation therapy, brachytherapy or cryotherapy.
    3. PSA ≥ 2.0 ng/ml above the most recent therapy nadir for patients who have received additional treatment in the recurrent setting
  • Patient must have undergone standard-of-care restaging that does not clearly identify site(s) of active disease, or such prior studies must show equivocal findings for which further work-up is considered necessary to make clinical decision. Standard staging examinations may include one or more of the following: CT or MRI, bone imaging (either Tc-99m bisphosphonate scintigraphy MDP or F-18 sodium fluoride PET), or In-111 capromab pendetide scintigraphy.
  • Age ≥ 18 years.
  • Patient must be able to tolerate PET/CT imaging.
  • Patient must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

  • Patient must not have claustrophobia that would preclude PET/CT imaging or other contraindications to CT imaging.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02531672

Contacts
Contact: Heiko Schӧder, MD 212-639-2079
Contact: Wolfgang Weber, MD 212-639-7373

Locations
United States, New York
Memorioal Sloan Kettering Cancer Center
New York, New York, United States, 10065
Contact: Heiko Schoder, MD    212-639-2079      
Contact: Wolfgang Weber, MD    212-639-7373      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Heiko Schӧder, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02531672     History of Changes
Other Study ID Numbers: 15-117 
Study First Received: August 20, 2015
Last Updated: August 20, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan Kettering Cancer Center:
11C-choline
Positron Emission Tomography
15-117

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Choline
Antimetabolites
Central Nervous System Agents
Gastrointestinal Agents
Hypolipidemic Agents
Lipid Regulating Agents
Lipotropic Agents
Molecular Mechanisms of Pharmacological Action
Nootropic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on February 04, 2016