PSMA PET Imaging of Recurrent Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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PSMA PET Imaging of Recurrent Prostate Cancer

Conditions
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Prostate Adenocarcinoma, Prostate Cancer

Intervention / Treatment
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* Drug: Ga-HBED-iPSMA PET
* Diagnostic Test: PET/CT
* Diagnostic Test: MRI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ga-HBED-iPSMA PET with CT or MRI<br>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<br>* 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.<br>Diagnostic Test: PET/CT<br>* 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.<br>Diagnostic Test: MRI<br>* 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.<br>|
| Active Comparator: Ga-HBED-iPSMA PET with MRI<br>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<br>* 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.<br>Diagnostic Test: MRI<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease localization by PSMA PET/MR |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, prostatectomy, biochemical recurrence, Ga-HBED-iPSMA, 16-306