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PSMA PET Imaging of Recurrent Prostate Cancer

Primary Purpose

Prostate Adenocarcinoma, Prostate Cancer

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ga-HBED-iPSMA PET
PET/CT
MRI
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Adenocarcinoma focused on measuring prostate cancer, prostatectomy, biochemical recurrence, Ga-HBED-iPSMA, 16-306

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (Consent only)
  • Memorial Sloan Kettering Monmouth (Consent only)
  • Memorial Sloan Kettering Bergen (Consent only )
  • Memorial Sloan Kettering Commack (Consent only)
  • Memorial Sloan Kettering Westchester (Consent only)
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Nassau (Consent only)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ga-HBED-iPSMA PET with CT or MRI

Ga-HBED-iPSMA PET with MRI

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Disease localization by PSMA PET/MR

Secondary Outcome Measures

PSA relapse free survival in patients undergoing PSMA PET/MR guided SRT
Incidence of Treatment-Emergent Adverse Events assessed by common terminology criteria for adverse events (CTCAE v4.0)
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)

Full Information

First Posted
June 27, 2017
Last Updated
June 29, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03204123
Brief Title
PSMA PET Imaging of Recurrent Prostate Cancer
Official Title
PSMA PET Imaging of Recurrent Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 26, 2017 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma, Prostate Cancer
Keywords
prostate cancer, prostatectomy, biochemical recurrence, Ga-HBED-iPSMA, 16-306

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1171 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ga-HBED-iPSMA PET with CT or MRI
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ga-HBED-iPSMA PET with MRI
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ga-HBED-iPSMA PET
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/CT
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI
Intervention Description
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 Measure Information:
Title
Disease localization by PSMA PET/MR
Time Frame
2 years
Secondary Outcome Measure Information:
Title
PSA relapse free survival in patients undergoing PSMA PET/MR guided SRT
Time Frame
2 years
Title
Incidence of Treatment-Emergent Adverse Events assessed by common terminology criteria for adverse events (CTCAE v4.0)
Description
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)
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heiko Schöder, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Consent only)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth (Consent only)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen (Consent only )
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Commack (Consent only)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester (Consent only)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Nassau (Consent only)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

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PSMA PET Imaging of Recurrent Prostate Cancer

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