Back to results68 Ga-PSMA for High Risk Prostate Cancer
Primary Purpose
Prostate Cancer, High Risk
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
68Ga-PSMA
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring PSMA, 68 Ga
Eligibility Criteria
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).
- Post radical prostatectomy (RP), PSA greater than or equal to 0.2 ng/ml measured more than 6 weeks after RP.
- 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.
Sites / Locations
- Houston Methodist
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68 Ga PSMA
Arm Description
Comparison between the results of 68 Ga-PSMA PET/CT to conventional imaging (bone scan, CT) in men with high risk prostate cancer.
Outcomes
Primary Outcome Measures
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.
Proportion of Patients Which Clinical Management Was Altered
Number of patients in which 68GA-PSMA-11 PET/CT altered the planned clinical management.
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT04614363
First Posted
October 8, 2020
Last Updated
August 24, 2023
Sponsor
The Methodist Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04614363
Brief Title
68 Ga-PSMA for High Risk Prostate Cancer
Official Title
Comparison of 68 Ga-PSMA Positron Emission Tomography (PET)/CT to Conventional Imaging in Men With High Risk Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
February 26, 2022 (Actual)
Study Completion Date
April 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Methodist Hospital Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, High Risk
Keywords
PSMA, 68 Ga
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
All subjects will receive the Investigational Product.
Masking
None (Open Label)
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.
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
68 Ga PSMA
Arm Type
Experimental
Arm Description
Comparison between the results of 68 Ga-PSMA PET/CT to conventional imaging (bone scan, CT) in men with high risk prostate cancer.
Intervention Type
Drug
Intervention Name(s)
68Ga-PSMA
Other Intervention Name(s)
68 Ga-PSMA 11
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of Patients With Lymph Node Involvement
Description
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
Title
Proportion of Patients Which Clinical Management Was Altered
Description
Number of patients in which 68GA-PSMA-11 PET/CT altered the planned clinical management.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Intensity of Uptake as a Predictor of Clinical Outcome or Aggressiveness
Description
Uptake intensity detected on PET/CT in the prostate and outside of the prostate
Time Frame
18 months
Title
Number of Patients With Suspicious Lesions
Description
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Post radical prostatectomy (RP), PSA greater than or equal to 0.2 ng/ml measured more than 6 weeks after RP.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Miles, MD
Organizational Affiliation
The Methodist Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Houston Methodist
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
68 Ga-PSMA for High Risk Prostate Cancer
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