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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 : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Prostate Adenocarcinoma Prostate Cancer Drug: Ga-HBED-iPSMA PET Diagnostic Test: PET/CT Diagnostic Test: MRI Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PSMA PET Imaging of Recurrent Prostate Cancer
Actual Study Start Date : June 26, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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 1-3 hours 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.

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.
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: 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.




Primary Outcome Measures :
  1. Disease localization by PSMA PET/MR [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. PSA relapse free survival in patients undergoing PSMA PET/MR guided SRT [ Time Frame: 2 years ]
  2. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03204123


Contacts
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Contact: Heiko Schöder, MD 212-639-2079 schoderh@mskcc.org
Contact: Michael Zelefsky, MD 212-639-6802

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Consent only) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Heiko Schöder, MD    212-639-2079      
Memoral Sloan Kettering Monmouth (Consent only) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Heiko Schoder, MD    212-639-2079      
Memorial Sloan Kettering Bergen (Consent only ) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Heiko Schoder, MD    212-639-2079      
United States, New York
Memorial Sloan Kettering Commack (Consent only) Recruiting
Commack, New York, United States, 11725
Contact: Heiko Schöder, MD    212-639-2079      
Memoral Sloan Kettering Westchester (Consent only) Recruiting
Harrison, New York, United States, 10604
Contact: Heiko Schöder, MD    212-639-2079      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Heiko Schöder, MD    212-639-2079      
Memorial Sloan Kettering Nassau (Consent only) Recruiting
Uniondale, New York, United States, 11553
Contact: Heiko Schoder, MD    212-639-2079      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Heiko Schöder, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03204123     History of Changes
Other Study ID Numbers: 16-306
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
prostate cancer
prostatectomy
biochemical recurrence
Ga-HBED-iPSMA
16-306
Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
N,N'-bis(2-hydroxybenzyl)ethylenediamine-N,N'-diacetic acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action