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68 Ga-PSMA for High Risk Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04614363
Recruitment Status : Completed
First Posted : November 4, 2020
Results First Posted : December 29, 2022
Last Update Posted : April 27, 2023
Sponsor:
Information provided by (Responsible Party):
Brian Miles, The Methodist Hospital Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer High Risk Drug: 68Ga-PSMA Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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.
Primary Purpose: Diagnostic
Official Title: Comparison of 68 Ga-PSMA Positron Emission Tomography (PET)/CT to Conventional Imaging in Men With High Risk Prostate Cancer
Actual Study Start Date : October 13, 2020
Actual Primary Completion Date : February 26, 2022
Actual Study Completion Date : April 25, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: 68 Ga PSMA
Comparison between the results of 68 Ga-PSMA PET/CT to conventional imaging (bone scan, CT) in men with high risk prostate cancer.
 Drug: 68Ga-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.
Other Name: 68 Ga-PSMA 11


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Patients With Lymph Node Involvement [ Time Frame: 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.

  2. Proportion of Patients Which Clinical Management Was Altered [ Time Frame: 18 months ]
    Number of patients in which 68GA-PSMA-11 PET/CT altered the planned clinical management.


Secondary Outcome Measures :
  1. Intensity of Uptake as a Predictor of Clinical Outcome or Aggressiveness [ Time Frame: 18 months ]
    Uptake intensity detected on PET/CT in the prostate and outside of the prostate

  2. Number of Patients With Suspicious Lesions [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).

  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04614363


Locations
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United States, Texas
Houston Methodist
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital Research Institute
Investigators
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Principal Investigator: Brian Miles, MD The Methodist Hospital Research Institute
  Study Documents (Full-Text)

Documents provided by Brian Miles, The Methodist Hospital Research Institute:
Study Protocol and Statistical Analysis Plan  [PDF] July 8, 2021

More Information
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Responsible Party: Brian Miles, Principal Investigator, The Methodist Hospital Research Institute
ClinicalTrials.gov Identifier: NCT04614363    
Other Study ID Numbers: Pro00026240
First Posted: November 4, 2020    Key Record Dates
Results First Posted: December 29, 2022
Last Update Posted: April 27, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brian Miles, The Methodist Hospital Research Institute:
PSMA
68 Ga
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
 Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Gallium 68 PSMA-11
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action