Phase 3 N=109 Diagnostic

Expanded Access to Diagnostic Imaging for Staging of Recurrent Prostate Cancer

Metastatic Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02260817 ↗

Enrolled (actual)

109

Serious AEs

0.0%

Results posted

Dec 2019

Primary outcome: Primary: Evidence of Metastatic Prostate Cancer — 0; 36; 0; 10 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 11C-choline Injection (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Global Isotopes, LLC d/b/a Zevacor Molecular
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Evidence of Metastatic Prostate Cancer	0; 36; 0; 10; 0; 11	—
PRIMARY Sensitivity of 11C Choline PET Imaging Scans	97.29	—
PRIMARY Specificity of 11C Choline PET Imaging Scans	47.61	—
PRIMARY Positive Predictive Value (PPV) of 11C Choline PET Imaging Scans	76.59	—
PRIMARY Negative Predictive Value (NPV) of 11C Choline PET Imaging Scans	90.90	—
PRIMARY Count of Participants With Positive or Negative PET, CT, or MRI Modalities Resulting in Prostate Cancer (PCa) Confirmation	11; 6; 11; 8	—
SECONDARY Median Age at Primary Treatment	63	—
SECONDARY Median PSA at Diagnosis of Arm 2 Participants	13.07	—
SECONDARY Clinical T (cT) Stage of Arm 2 Participants	0; 34; 0; 20	—
SECONDARY Median Primary Biopsy Gleason Score of Arm 2 Participants	7	—
SECONDARY Primary Treatment Modality of Arm 2 Participants	1; 1; 2; 4; 1; 1	—
SECONDARY Pathological Stage (pT) of Prostate Cancer (PC) of Arm 2 Participants	1; 14; 9; 8	—
SECONDARY Primary Surgical Margins of Arm 2 Participants	13; 19	—
SECONDARY Primary Positive Lymph Node Ratio of Arm 2 Participants	3; 25; 4	—
SECONDARY Additional Treatment and Type for Arm 2 Participants	3; 11; 1; 1; 1; 31	—
SECONDARY Median Months to Biochemical Relapse of Arm 2 Participants	40	—
SECONDARY Median Age of Arm 2 Participant at PET Imaging	69	—
SECONDARY Median PSA of Arm 2 Participant at PET Imaging	3.58	—
SECONDARY Median PSA Doubling Time of Arm 2 Participants at PET Imaging	4.91	—
SECONDARY Median PSA Velocity of Arm 2 Participants at PET Imaging	0.09	—
SECONDARY ADT (Androgen Deprivation Therapy) in Participant at PET Imaging	48; 8	—

Summary

This Phase 3 study will target approximately 100 men over age 18 who have a biochemical relapse or other evidence of relapse of prostate cancer after primary treatment. The purpose of this study is to: A. Provide expanded access the drug 11C-choline. B. Determine the performance characteristics (sensitivity, specificity, positive predictive value, negative predictive value) of 11C-choline PET/Computed Tomography (CT) and PET/Magnetic Resonance Imaging (MRI) in the detection of metastatic prostate cancer in patients with biochemical relapse of prostate cancer after primary treatment in a prospective manner. C. Determine the optimal Prostate-Specific Antigen (PSA) trigger value in 11C-choline PET/CT and PET/MRI positive patients through a prospective study. D. Determine factors that predict a confirmed positive 11C-choline PET/CT and PET/MRI using a multivariable analysis of clinical and pathologic data collected prospectively. E. Compare the individual performance characteristics of 11C-choline PET/CT and 11C-choline PET/MRI and the combination of 11C-choline PET/CT and PET/MRI Study Protocol: 1. Patients entered into the study will undergo a 11C-choline PET CT scan and MRI scan. 2. The CT and MRI images will be evaluated for evidence of metastatic prostate cancer. 3. The 11C-choline PET CT and MRI images will be evaluated for evidence of metastatic prostate cancer. 4. Evidence of metastasis on conventional imaging or 11C-choline PET will be confirmed with biopsy or surgical pathology when possible, or by response to treatment on subsequent imaging. 5. Rates of confirmed metastasis between conventional CT and MRI images will be compared with the 11C-choline PET CT and MRI images. 6. Upon conclusion of each imaging protocol, the referring physician will receive written documentation of the results. At this time, the patient will be considered off study and no further follow up is required.

Eligibility Criteria

Inclusion Criteria

For biochemical relapse after primary treatment
PSA > 0.2 ng/ml after radical prostatectomy confirmed at that level or higher on a subsequent test 3 months later
PSA increase >2 ng/ml from nadir following radiation therapy
PSA increase >2 ng/ml from nadir following radiation therapy plus androgen deprivation therapy with nadir defined with normalized testosterone level
Two consecutive PSA increases from nadir level after androgen blockade or androgen suppression therapy
Kidney function with GFR > 60 mL/sec/1.73m2 and Creatinine or equal to 60 mL/sec/1.73m2, PET/CT will be completed with contrast
if GFR is than 1.7 mg, Radiology will follow ACR recommendations as outlined in department policy.
No known allergy to iodinated radiologic contrast media
Able to have MRI based on screening evaluation. If patient is found to be MRI incompatible, the 11C-choline PET/MRI portion of the study will not be completed. Please see the provided contact numbers for further options.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

Exclusion Criteria

ECOG Performance Status > 2.
Concurrent malignancy, i.e. colon cancer.
Treatment for another malignancy except superficial skin cancer within 5 years

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02260817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.