PSMA PET Imaging of Recurrent Prostate Cancer

• ClinicalTrials.gov Identifier: NCT03204123
• Recruitment Status: Active, not recruiting
• First Posted: June 29, 2017
• Last Update Posted: August 2, 2022
• Sponsor: Memorial Sloan Kettering Cancer Center
• Information provided by (Responsible Party): Memorial Sloan Kettering Cancer Center

Tracking Information

• First Submitted Date: June 27, 2017
• First Posted Date: June 29, 2017
• Last Update Posted Date: August 2, 2022
• Actual Study Start Date: June 26, 2017
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 28, 2017): Disease localization by PSMA PET/MR [ Time Frame: 2 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PSMA PET Imaging of Recurrent Prostate Cancer
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

• Prostate Adenocarcinoma
• Prostate Cancer

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: July 6, 2022): 1171
• Original Estimated Enrollment (submitted: June 28, 2017): 35
• Estimated Study Completion Date: June 2023
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03204123
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Memorial Sloan Kettering Cancer Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Memorial Sloan Kettering Cancer Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Heiko Schöder, MD; Memorial Sloan Kettering Cancer Center

• PRS Account: Memorial Sloan Kettering Cancer Center
• Verification Date: August 2022