Prostate Adenocarcinoma, Prostate Cancer
Conditions
Keywords
prostate cancer, prostatectomy, biochemical recurrence, Ga-HBED-iPSMA, 16-306
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.
Interventions
DRUGGa-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_TESTPET/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_TESTMRI
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease localization by PSMA PET/MR | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHeiko Schöder, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed