Stage III Prostate Adenocarcinoma, Stage II Prostate Adenocarcinoma
Conditions
Brief summary
This phase 2-3 trial studies the utility of 68-gallium (68Ga)-prostate-specific membrane antigen 11 (PSMA-11) positron emission tomography/magnetic resonance imaging (PET/MRI) to find tumors in patients with prostate cancer who are undergoing resection surgery for prostate cancer that is prognostically expected to spread quickly (intermediate-risk) or is likely to come back or spread (high-risk). Diagnostic procedures, such as PET/MRI, may help find and diagnose prostate cancer, and reveal out how far the disease has spread. Radioactive drugs, such as 68Ga-PSMA-11, may bind to tumor cells that have specific receptors, and may allow doctors to see smaller tumors than the standard of care contrast-enhanced computed tomography (CT) or MRI scan.
Detailed description
OBJECTIVES: 1. To evaluate 68Ga-PSMA-11 PET/MRI for detection of tumor metastases in patients with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. 2. To assess sensitivity (positive predictive value) and specificity (negative predictive value) of 68Ga-PSMA-11 PET/MRI for the detection of regional nodal metastases compared to pathology at radical prostatectomy. OUTLINE: Participants will receive 68Ga-PSMA-11 intravenously (IV). Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection. After completion of study, patients are followed up at 24 to 48 hours.
Interventions
DRUG68Ga-PSMA-11
Undergo 68Ga-PSMA-11 PET/MRI
PROCEDUREMagnetic resonance imaging (MRI)
Undergo 68Ga-PSMA-11 PET/MRI
PROCEDUREPositron Emission Tomography (PET)
Undergo 68Ga-PSMA-11 PET/MRI
Sponsors
National Cancer Institute (NCI)
Andrei Iagaru
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
* Biopsy-proven prostate adenocarcinoma * Planned prostatectomy with lymph node dissection * Intermediate- to high-risk disease (as determined by elevated prostate-specific antigen (PSA) \[PSA \> 10\], T stage \[T2b or greater\], Gleason score \[Gleason score \> 6\] or other risk factors) * Karnofsky performance status of ≥ 50 \[or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent\] * Diagnostic CT or MRI performed within 90 days of the research PET * Able to provide written consent
Exclusion criteria
* Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam * Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy, including focal ablation techniques (HiFu) * Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and surgery * Metallic implants (contraindicated for MRI)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 68Ga-PSMA-11 PET Detection of Prostate Cancer Metastasized to Lymph Nodes | 1 Day | 68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect regional nodal and distant metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. The data will be analyzed by imaging interpretation. Each participant will be interpreted as either positive or negative for the presence of metastatic disease by 68Ga-PSMA PET/MRI, as assessed by imaging interpretation. The outcome will be expressed as the number of participants with metastatic disease, as identified by PET/MRI, a number without dispersion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histopathologic Detection of Prostate Cancer Metastasized to Lymph Nodes | 1 Day | Participants that undergo prostatectomy will be evaluated for prostate cancer metastasis to the lymph nodes as determined by histopathology. Each participants will be interpreted as either positive or negative for the presence of metastatic disease by histopathology. The outcome will be expressed as the number of participants with metastatic disease, as identified by histopathology, a number without dispersion. |
| Sensitivity of 68Ga-PSMA-11 PET/MRI | 1 Day | 68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. For participants that undergo both procedures (68Ga-PSMA PET/MRI and prostatectomy), sensitivity of the 68Ga-PSMA PET/MRI detection of metastatic prostate cancer will be determined. For an individual participant, sensitivity means the 2 assessments are in agreement that the participant truly has (ie, true-positive) have the condition being tested for (ie, metastatic prostate cancer). The outcome is reported as the percentage of participants for which the 2 assessments are in agreement that metastatic prostate cancer is detected (true-positive), a number without dispersion. |
| Specificity of 68Ga-PSMA-11 PET/MRI | 1 Day | 68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. For participants that undergo both procedures (68Ga-PSMA PET/MRI and prostatectomy), specificity of the 68Ga-PSMA PET/MRI detection of metastatic prostate cancer will be determined. For an individual participant, specificity means the 2 assessments are in agreement that the participant does not (ie, true-negative) have the condition being tested for (ie, metastatic prostate cancer). The outcome is reported as the percentage of participants for which the 2 assessments are in agreement that metastatic prostate cancer is not detected (true-negative), a number without dispersion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 68Ga-PSMA PET/MRI Patients receive 68Ga-PSMA-11 IV. Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection.
68Ga-PSMA-11: Undergo 68Ga-PSMA-11 PET/MRI Magnetic resonance imaging (MRI): Undergo 68Ga-PSMA-11 PET/MRI Positron Emission Tomography (PET): Undergo 68Ga-PSMA-11 PET/MRI | 74 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | 68Ga-PSMA PET/MRI |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 43 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 56 Participants |
| Region of Enrollment United States | 74 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 74 |
| other Total, other adverse events | 0 / 74 |
| serious Total, serious adverse events | 0 / 74 |
Outcome results
Primary
68Ga-PSMA-11 PET Detection of Prostate Cancer Metastasized to Lymph Nodes
68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect regional nodal and distant metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. The data will be analyzed by imaging interpretation. Each participant will be interpreted as either positive or negative for the presence of metastatic disease by 68Ga-PSMA PET/MRI, as assessed by imaging interpretation. The outcome will be expressed as the number of participants with metastatic disease, as identified by PET/MRI, a number without dispersion.
Time frame: 1 Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 68Ga-PSMA PET/MRI | 68Ga-PSMA-11 PET Detection of Prostate Cancer Metastasized to Lymph Nodes | 19 Participants |
Secondary
Histopathologic Detection of Prostate Cancer Metastasized to Lymph Nodes
Participants that undergo prostatectomy will be evaluated for prostate cancer metastasis to the lymph nodes as determined by histopathology. Each participants will be interpreted as either positive or negative for the presence of metastatic disease by histopathology. The outcome will be expressed as the number of participants with metastatic disease, as identified by histopathology, a number without dispersion.
Time frame: 1 Day
Population: Some participants elected to have alternatives to prostatectomy, such as external beam radiation or observation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 68Ga-PSMA PET/MRI | Histopathologic Detection of Prostate Cancer Metastasized to Lymph Nodes | 16 Participants |
Secondary
Sensitivity of 68Ga-PSMA-11 PET/MRI
68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. For participants that undergo both procedures (68Ga-PSMA PET/MRI and prostatectomy), sensitivity of the 68Ga-PSMA PET/MRI detection of metastatic prostate cancer will be determined. For an individual participant, sensitivity means the 2 assessments are in agreement that the participant truly has (ie, true-positive) have the condition being tested for (ie, metastatic prostate cancer). The outcome is reported as the percentage of participants for which the 2 assessments are in agreement that metastatic prostate cancer is detected (true-positive), a number without dispersion.
Time frame: 1 Day
Population: Some participants elected to have alternatives to prostatectomy, such as external beam radiation or observation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 68Ga-PSMA PET/MRI | Sensitivity of 68Ga-PSMA-11 PET/MRI | 56.2 Percentage of participants |
Secondary
Specificity of 68Ga-PSMA-11 PET/MRI
68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. For participants that undergo both procedures (68Ga-PSMA PET/MRI and prostatectomy), specificity of the 68Ga-PSMA PET/MRI detection of metastatic prostate cancer will be determined. For an individual participant, specificity means the 2 assessments are in agreement that the participant does not (ie, true-negative) have the condition being tested for (ie, metastatic prostate cancer). The outcome is reported as the percentage of participants for which the 2 assessments are in agreement that metastatic prostate cancer is not detected (true-negative), a number without dispersion.
Time frame: 1 Day
Population: Some participants elected to have alternatives to prostatectomy, such as external beam radiation or observation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 68Ga-PSMA PET/MRI | Specificity of 68Ga-PSMA-11 PET/MRI | 85.4 Percentage of participants |