Prostate Cancer
Conditions
Keywords
Prostate cancer, PET/CT
Brief summary
The main purpose of this phase II trial study is to determine whether a positron emission tomography (PET)/computed tomography (CT) scan using 18F-DCFPyL affects the clinical management plan in Veterans. In this study, the management plan prior to and after 18F-DCFPyL PET/CT will be recorded by specific questionnaires and corresponding changes in management will be analyzed. The scan will be used to see how the disease has spread. Both the treatment strategies and probable disease outcomes as relevant to clinical endpoints will be assessed. This study is open to Veterans only.
Interventions
DRUG18F-DCFPyL
Study participants will receive intravenous administration of 18F-DCFPyL and undergo a PET/CT imaging study. Patients may be reenrolled in the study, if 18F-DCFPyL PET/CT is performed for subsequent management decision.
Sponsors
VA Greater Los Angeles Healthcare System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants who fulfill criteria for initial staging or restaging as outlined below: 1. Initial treatment strategy decisions (initial staging) All participants with histologically proven prostate cancer or strong suspicion of prostate adenocarcinoma based on very high PSA levels (\>50 ng/mL) who require an initial treatment/management decision who may be candidate for any of the following strategies: A) Surgery B) External radiation therapy (RT) C) Other focal therapies D) Systemic medical treatment E) Watchful waiting 2. Assessment for Subsequent treatment strategy (restaging), any of the following: A) Participants with biochemical recurrence who are potential candidates for any salvage treatment. Biochemical recurrence is defined by rising PSA after definitive therapy with prostatectomy or radiation therapy, as any of the following: 1. Post radical prostatectomy (RP): PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP 2. Post-radiation therapy : Nadir + greater than or equal to 2 ng/mL rise in PSA B) Participants with known prostate cancer who undergo restaging because of new symptoms C) Participants with known metastatic prostate cancer who undergo restaging because of rising PSA with negative or inconclusive conventional imaging D) Participants with known prostate cancer who are treated medically or with RLT in whom response to treatment is assessed * Capability to provide written informed consent * Able to remain still for duration of each imaging procedure (about 30 minutes) \* Participants may be reenrolled in the study, if 18F-DCFPyL PET/CT is performed for subsequent management decision.
Exclusion criteria
* Less than 18 years-old at the time of radiotracer administration * Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) * Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance. * Inability to provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PRIMARY OBJECTIVES: I. To Determine the Impact of 18F-DCFPyL PET/CT on Initial and Subsequent Treatment Strategies of Patients With Prostate Cancer. | 6 months | the percentage of patients whose management was changed after PSMA PET/CT |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PET/CT Arm Subjects receive a PET/CT scan.
18F-DCFPyL: Study participants will receive intravenous administration of 18F-DCFPyL and undergo a PET/CT imaging study. Patients may be reenrolled in the study, if 18F-DCFPyL PET/CT is performed for subsequent management decision. | 239 |
| Total | 239 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | PET/CT Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 206 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 86 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 32 Participants |
| Race (NIH/OMB) White | 107 Participants |
| Region of Enrollment United States | 239 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 239 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 239 |
| other Total, other adverse events | 0 / 239 |
| serious Total, serious adverse events | 0 / 239 |
Outcome results
Primary
PRIMARY OBJECTIVES: I. To Determine the Impact of 18F-DCFPyL PET/CT on Initial and Subsequent Treatment Strategies of Patients With Prostate Cancer.
the percentage of patients whose management was changed after PSMA PET/CT
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PET/CT Arm | PRIMARY OBJECTIVES: I. To Determine the Impact of 18F-DCFPyL PET/CT on Initial and Subsequent Treatment Strategies of Patients With Prostate Cancer. | 66.2 Percent |