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PSMA PET Imaging of Recurrent Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03204123
Recruitment Status : Recruiting
First Posted : June 29, 2017
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE June 27, 2017
First Posted Date  ICMJE June 29, 2017
Last Update Posted Date April 17, 2020
Actual Study Start Date  ICMJE June 26, 2017
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2017)
Disease localization by PSMA PET/MR [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2017)
  • PSA relapse free survival in patients undergoing PSMA PET/MR guided SRT [ Time Frame: 2 years ]
  • Incidence of Treatment-Emergent Adverse Events assessed by common terminology criteria for adverse events (CTCAE v4.0) [ Time Frame: 2 years ]
    The safety and tolerability of 68Ga-HBED-iPSMA will be followed by assessing the incidence, nature and severity of toxicities by common terminology criteria for adverse events (CTCAE v4.0)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PSMA PET Imaging of Recurrent Prostate Cancer
Official Title  ICMJE PSMA PET Imaging of Recurrent Prostate Cancer
Brief Summary The purpose of this study is to see if a new diagnostic research agent named 68Ga-HBED-CC-PSMA can show prostate cancer on a PET/CT scan that cannot be seen on other standard imaging even when the PSA levels are very low.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Prostate Adenocarcinoma
  • Prostate Cancer
Intervention  ICMJE
  • Drug: Ga-HBED-iPSMA PET
    Patients will be injected with 100-300 MBq of 68Ga-HBED-iPSMA and after a waiting of 60-90 minutes patients will be scanned from mid-skull to mid-thigh.
  • Diagnostic Test: PET/CT
    PET/CT will be acquired using a GE 710 or 690 time-of-flight PET/CT scanner. Following a waiting period of 60-90 minutes post 68Ga-HBED-iPSMA administration, patients will be scanned from top of the skull to mid-thigh. Images will be acquired with patients in a supine position with their arms raised above their head. If patients cannot raise their arms above the head, the arms will be comfortably positioned and secured by the side of the patient. The PET may be combined with a CT scan as a PET/CT or a MRI scan as PET/MR.
  • Diagnostic Test: MRI
    Patients may undergo a diagnostic MRI of the prostate, other body parts or a whole-body MRI at the same imaging session as clinically indicated.
Study Arms  ICMJE
  • Active Comparator: Ga-HBED-iPSMA PET with CT or MRI
    Participants will have a PET scan with Ga-HBED-iPSMA. PET may be combined with CT or MRI at the discretion of the referring clinician.
    Interventions:
    • Drug: Ga-HBED-iPSMA PET
    • Diagnostic Test: PET/CT
    • Diagnostic Test: MRI
  • Active Comparator: Ga-HBED-iPSMA PET with MRI
    Participants will have a PET scan with Ga-HBED-iPSMA and will be combined with MRI. If PET/MR imaging is not available, PET/CT imaging may be substituted. This arm will be closed to accrual and these patients will be analyzed separately.
    Interventions:
    • Drug: Ga-HBED-iPSMA PET
    • Diagnostic Test: MRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 7, 2020)
1400
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2017)
35
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Biopsy proven adenocarcinoma of the prostate
  • Initially treated with definitive local therapy (surgery and radiation therapy are the most common treatments, but other treatments are also eligible)
  • For patients initially treated with surgery, radiation therapy, brachytherapy, or cryotherapy:

    • PSA ≥ 0.2 ng/mL in at least two consecutive tests within 6 months of date of consent for patients
    • Note: The most recent PSA value must be within 6 weeks of consent
  • For patients who have received additional treatment in the recurrent or metastatic setting:

    ° PSA ≥ 2 ng/ml above the most recent therapy nadir

  • Age ≥ 18 years
  • Patient must be able to tolerate PET/CT or PET/MR imaging

Exclusion Criteria:

  • Patient with claustrophobia that would preclude PET/CT or PET/MR imaging or other contraindications to CT imaging.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Heiko Schöder, MD 212-639-2079 schoderh@mskcc.org
Contact: Michael Zelefsky, MD 212-639-6802
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03204123
Other Study ID Numbers  ICMJE 16-306
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Heiko Schöder, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP