68Ga PSMA PET for Patients With Biochemical Recurrence of Prostate Cancer

68Ga PSMA-HBED-CC PET in Patients With Biochemical Recurrence

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03389451

Enrollment

Registered

2018-01-03

Start date

2018-02-16

Completion date

2019-07-23

Last updated

2024-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer, Prostatic Cancer Metastatic, Prostatic Cancer Recurrent, Prostatic Neoplasm, Prostatic Neoplasms, Castration-Resistant

Keywords

68Ga-PSMA-11, (68Ga)Glu-urea-Lys(Ahx)-HBED-CC, 68Ga PSMA-HBED-CC

Brief summary

This study investigates if a new prostate-specific membrane antigen (PSMA) drug makes prostate cancer easier to identify in positron-emission tomography (PET) imaging. If this works, prostate cancer treatments can be prescribed that match the location of the disease. PSMA is radiolabeled with Gallium-68 (Ga-68). This means a participant receives a small dose of radiation from the drug - less than the annual radiation limit for a medical worker. To test this new drug, participants will receive an injection of Ga-68 PSMA and then have a PET scan. This PET scan, and the reported results, will be entered into the medical record and shared with the treating oncologists.

Detailed description

This study evaluates PSMA-HBED-CC labelled with Gallium-68, abbreviated 68Ga PSMA. This is a radiotracer that attaches to receptors in the membrane of prostate cancer cells. The 68Ga PSMA is identified using a positron emission tomography (PET) scanner. It is believed that 68Ga PSMA will identify prostate cancer more precisely than normal imaging methods (MRI, CT, or ultrasound). Imaging is key to successful treatment - disease must be identified to be treated. Men who have biochemical recurrence of prostate cancer are invited to test 68Ga PSMA. Participants undergo the 68Ga PSMA PET scan before further treatment. Clinical information, including any MRI, CT, or ultrasound imaging and biopsy/surgery information, will be used to determine if the 68Ga PSMA PET imaging was better than the standard imaging. The study team will collect this information for about 1 year after the PSMA scan. Depending on findings, participants may be invited back for a second 68Ga PSMA scan. This is done if the first scan showed positive lymph nodes or soft tissue metastases but a surgery or biopsy result does not. The results from these scans will be shared with the participant. Results will also be entered into the participant's medical record and shared with the treating oncologists.

Interventions

DRUGGa-68 PSMA-HBED-CC PET

Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Pathologically proven prostate adenocarcinoma * Rising prostate-specific antigen (PSA )after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy) * If post-radical prostatectomy, PSA \> 0.2 ng/mL measured \> 6 weeks post-operative and confirmed persistent PSA \> 0.2 ng/mL (AUA recommendation for biochemical recurrence) * If post-radiation therapy, PSA that is ≥ 2 mg/mL rise above PSA nadir (ASTRO recommendation for biochemical recurrence) * Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations) * No other malignancy within the past 2 years (skin basal cell or cutaneous superficial squamous cell carcinoma or superficial bladder cancer are exempt from this criterion) * Karnofsky performance status (KPS) ≥ 50 (ECOG/WHO of 0, 1, or 2) * Ability to understand and willingness to provide informed consent

Exclusion criteria

* Cannot receive furosemide * History of Stevens Johnson syndrome * History or diagnosis of Paget's disease * Malignancy other than current disease under study * Allergy to sulfa or sulfa-containing medications * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection on a Per Patient Basis	Up to 12 months after 68Ga PSMA PET scan	Sensitivity will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.

Secondary

Measure	Time frame	Description
Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Tumor Location on a Per Patient Basis	Up to 12 months after 68Ga PSMA PET scan	Positive predictive value will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.
Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Prostate Bed Lesions on a Per Patient Basis	Up to 12 months after 68Ga PSMA PET scan	Positive predictive value will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.
Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Regional Pelvic Nodal Metastases on a Per Patient Basis	Up to 12 months after 68Ga PSMA PET scan	Positive predictive value will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.
Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Extra-pelvic/Visceral Nodal Metastases on a Per Patient Basis	Up to 12 months after 68Ga PSMA PET scan	Positive predictive value will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.
Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Osseous Metastases on a Per Patient Basis	Up to 12 months after 68Ga PSMA PET scan	Positive predictive value will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.

Countries

United States

Participant flow

Participants by arm

Arm	Count
68Ga PSMA PET Scan Ga-68 PSMA-HBED-CC PET Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.	30
Total	30

Baseline characteristics

Characteristic	68Ga PSMA PET Scan
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	23 Participants
Age, Categorical Between 18 and 65 years	7 Participants
Age, Continuous	69 years
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	29 Participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	30 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 30
other Total, other adverse events	0 / 30
serious Total, serious adverse events	0 / 30

Outcome results

Primary

Sensitivity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection on a Per Patient Basis

Sensitivity will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.