PSMA PET Imaging of Recurrent Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- Ga-HBED-iPSMA PET
- Conditions
- Prostate Adenocarcinoma
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 1171
- Locations
- 7
- Primary Endpoint
- Disease localization by PSMA PET/MR
- Status
- Active, not recruiting
- Last Updated
- 9 months ago
Overview
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.
Investigators
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.
Arms & Interventions
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.
Intervention: Ga-HBED-iPSMA PET
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.
Intervention: PET/CT
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.
Intervention: MRI
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.
Intervention: Ga-HBED-iPSMA PET
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.
Intervention: MRI
Outcomes
Primary Outcomes
Disease localization by PSMA PET/MR
Time Frame: 2 years
Secondary Outcomes
- PSA relapse free survival in patients undergoing PSMA PET/MR guided SRT(2 years)
- Incidence of Treatment-Emergent Adverse Events assessed by common terminology criteria for adverse events (CTCAE v4.0)(2 years)