Prostate Cancer, High Risk
Conditions
Keywords
PSMA, 68 Ga
Brief summary
This is a prospective, single-center, open-label pilot study of 68GA-PSMA-11 given at a single time prior to PET/CT imaging in men with localized high risk prostate cancer or biochemical recurrence. The imaging agent (68 Ga-PSMA 11 will be administered on an outpatient basis. It will be administered prior to the PET/CT imaging. The objective is to evaluate the distribution of 68GA-PSMA-11 in tissues and to determine if this alters the planned clinical management.
Detailed description
This is a prospective, open label, single-center, single-arm, pilot diagnostic accuracy study to evaluate the tissue distribution of 68Ga-PSMA Positron Emission Tomography (PET)/CT in 80 patients with high risk localized prostate cancer or biochemical recurrence. Subjects will receive a single IV dose of 3-7 mCi of 68Ga-PSMA (study drug) followed by PET/CT imaging 60-90 minutes after injection. All patients will be closely monitored with vital signs (blood pressure and heart rate), before and 2 hours following radiotracer administration. Patients will receive a phone call 2 days following PET/CT to assess for adverse events. To minimize bias, all PET/CT images will be interpreted by a board-certified radiologist. The radiologist evaluating the images will be blinded to the final outcome, such as the histopathology of any biopsies and the outcome of subsequent imaging. Patients with study-defined high-risk features who are eligible and scheduled for radical prostatectomy will undergo 68Ga-PSMA-11 PET/CT injection. The results of the 68Ga-PSMA-11 PET/CT may alter patient management in one of several ways, including the decision to not pursue surgical extirpation (e.g. in the event of extensive distant metastasis) in favor of systemic therapy. It is also possible that the extent of surgical resection may be altered, such as non-regional pelvic or retroperitoneal lymph node dissection. The alteration in planned surgical treatment from standard of care will be recorded as a secondary-end point.
Interventions
DRUG68Ga-PSMA
All subjects enrolled in the study will receive a single IV dose of 3-7 mCi of 68 Ga-PSMA (study drug) followed by PET/CT imaging for detection of tumor location.
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
To minimize bias, all PET/CT images will be interpreted by a board certified radiologist. They will be blinded to the final outcome, such as histopathology of any biopsies and the outcome of subsequent imaging.
Intervention model description
All subjects will receive the Investigational Product.
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male aged 21 years or older * Ability to understand and provide written informed consent * All patients must have histopathological proven adenocarcinoma of the prostate * ECOG performance status 0-1 * No evidence of other malignancy (except squamous or basal cell skin cancers) * Consent to use acceptable form of birth control following the imaging period (condoms for a period of seven days after injection if sexually active) A. Inclusion criteria specific for the pre-prostatectomy group: Untreated prostate Cancer with high-risk features, as defined as having at least one of the following criteria: i. PSA ≥ 20.0 ng/mL ii. ISUP Gleason Grade Group 3, 4 or 5 iii. Clinical stage T3 B. Inclusion criteria specific for biochemical recurrence: (i) Histopathological proven prostate adenocarcinoma (ii)Rising PSA after definitive therapy with prostatectomy or radiation (therapy (external beam or brachytherapy). 1. Post radical prostatectomy (RP), PSA greater than or equal to 0.2 ng/ml measured more than 6 weeks after RP. 2. Post-radiation therapy, PSA that is equal to or greater than 2 ng/ml rise above PSA nadir
Exclusion criteria
* Unable to tolerate a PET/CT (e.g. unable to lie flat) * Recent history of a secondary malignancy in the past year, excluding non-melanoma skin cancer (non-metastatic) * Known allergic reactions to 68-Ga, or gadolinium-based contrast agents. * Treatment with another investigational drug or other intervention 2 years. * Patient has any medical, psychological or social condition that, in opinion of the investigator will make difficult for the participant to tolerate study intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With Lymph Node Involvement | 18 months | Number of patients with cTxNoMo (clinically localized disease) found on final histological examination to have lymph node involvement as determined by 68GA-PSMA-11 PET/CT. |
| Proportion of Patients Which Clinical Management Was Altered | 18 months | Number of patients in which 68GA-PSMA-11 PET/CT altered the planned clinical management. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of Uptake as a Predictor of Clinical Outcome or Aggressiveness | 18 months | Uptake intensity detected on PET/CT in the prostate and outside of the prostate |
| Number of Patients With Suspicious Lesions | 18 months | Number of patients in which 68Ga-PSMA 11 PET/CT showed suspicious lesions that are were not seen in standard diagnostic modalities of bone scan, CTs or MRI. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Localized High Risk Prostate Cancer Patients with high risk prostate cancer scheduled for prostatectomy will receive a single IV dose of 3-7 mCi of 68Ga-PSMA (study drug) followed by PET/CT imaging 60-90 minutes after injection. | 30 |
| Biochemical Recurrence Patients with biochemical recurrence post radical prostatectomy will receive a single IV dose of 3-7 mCi of 68Ga-PSMA (study drug) followed by PET/CT imaging 60-90 minutes after injection. | 50 |
| Total | 80 |
Baseline characteristics
| Characteristic | Localized High Risk Prostate Cancer | Biochemical Recurrence | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 31 Participants | 47 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 19 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 45 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 2 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 48 Participants | 70 Participants |
| Region of Enrollment United States | 30 participants | 50 participants | 80 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 30 Participants | 50 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 2 / 50 |
| other Total, other adverse events | 0 / 30 | 0 / 50 |
| serious Total, serious adverse events | 1 / 30 | 2 / 50 |
Outcome results
Primary
Proportion of Patients Which Clinical Management Was Altered
Number of patients in which 68GA-PSMA-11 PET/CT altered the planned clinical management.
Time frame: 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Localized High Risk Prostate Cancer | Proportion of Patients Which Clinical Management Was Altered | 2 Participants |
| Biochemical Recurrence | Proportion of Patients Which Clinical Management Was Altered | 30 Participants |
Primary
Proportion of Patients With Lymph Node Involvement
Number of patients with cTxNoMo (clinically localized disease) found on final histological examination to have lymph node involvement as determined by 68GA-PSMA-11 PET/CT.
Time frame: 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Localized High Risk Prostate Cancer | Proportion of Patients With Lymph Node Involvement | 4 Participants |
| Biochemical Recurrence | Proportion of Patients With Lymph Node Involvement | 28 Participants |
Secondary
Intensity of Uptake as a Predictor of Clinical Outcome or Aggressiveness
Uptake intensity detected on PET/CT in the prostate and outside of the prostate
Time frame: 18 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Localized High Risk Prostate Cancer | Intensity of Uptake as a Predictor of Clinical Outcome or Aggressiveness | SUV (mean) inside the prostate : mean SUV | 22.45 SUV |
| Localized High Risk Prostate Cancer | Intensity of Uptake as a Predictor of Clinical Outcome or Aggressiveness | SUV (mean) outside the prostate | 43.8 SUV |
| Biochemical Recurrence | Intensity of Uptake as a Predictor of Clinical Outcome or Aggressiveness | SUV (mean) inside the prostate : mean SUV | 0 SUV |
| Biochemical Recurrence | Intensity of Uptake as a Predictor of Clinical Outcome or Aggressiveness | SUV (mean) outside the prostate | 16.9 SUV |
Secondary
Number of Patients With Suspicious Lesions
Number of patients in which 68Ga-PSMA 11 PET/CT showed suspicious lesions that are were not seen in standard diagnostic modalities of bone scan, CTs or MRI.
Time frame: 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Localized High Risk Prostate Cancer | Number of Patients With Suspicious Lesions | 4 Participants |
| Biochemical Recurrence | Number of Patients With Suspicious Lesions | 17 Participants |