- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04644822
Safety and Efficacy of [18F]PSMA-1007 Injection in Suspected Persistent or Recurrent Prostate Cancer.
February 5, 2024 updated by: Centre for Probe Development and Commercialization
A Phase 3, Non-randomized, Open Label, Multi-centre Clinical Trial to Investigate the Safety and Efficacy of [18F]PSMA-1007 Injection in Men With Suspected Persistent or Recurrent Prostate Cancer.
This is a prospective, Phase 3 non-randomized, open label, multi-centre clinical trial to assess the safety and efficacy of [18F]PSMA-1007 Injection (investigational product or IP) in evaluating men with suspected persistent or recurrent disease (i.e., with biochemical failure), but with negative or equivocal conventional re-staging imaging (bone scan [BS] and computed tomography [CT] of abdomen and pelvis).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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London, Ontario, Canada, N6A 5W9
- London Health Sciences Centre
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Toronto, Ontario, Canada, M5G 2M9
- University Health Network - Princess Margaret Cancer Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Able to read and speak in English and provide informed consent
- Male, Age ≥ 18 years
- Prior primary treatment for prostate cancer with curative intent such as radical prostatectomy or radiotherapy for localized prostate cancer or other local or focal ablative therapy of the prostate
- Not currently on systemic therapy (adjuvant or salvage) including androgen deprivation therapy
Suspected progressive or persistent disease after primary treatment for prostate cancer and biochemical failure (BF) with current management according to the following:
- Following primary radical prostatectomy (with or without adjuvant or salvage radiotherapy to the prostate bed/pelvis), where BF is defined as rising PSA on at least 2 occasions measured at least 1 month apart and with the most recent PSA measured within 3 months prior to enrollment at > 0.1 ng/mL
- Following primary radiotherapy (with either brachytherapy, external beam radiotherapy or combined brachytherapy and radiotherapy) for localized disease, where BF is defined according to the Phoenix Definition, which is rising PSA on at least 2 occasions measured at least 1 month apart and with the most recent PSA measured within 3 months prior to enrollment greater than the nadir PSA + 2.0 ng/mL
- Following primary ablative therapy to the prostate given with radical intent such as prior HIFU (high intensity focused ultrasound) or cryotherapy or other ablative energy therapy with biochemical failure as defined by the Stuttgart Criteria (nadir PSA + 1.2 ng/mL within 3 months prior to enrollment )
- If PSA > 10 ng/mL, conventional imaging consisting of bone scan and CT scan within 3 months prior to consent that is either negative or equivocal.
Male subjects must be either:
- Documented by medical records or physician's note to be surgically sterile or,
- If capable of fathering a child, commit to the use of a barrier method of contraception, or agree to remain abstinent for 48 hours post-administration of the IP
- Male subjects must agree to not donate sperm for 48 hours post-administration of the IP
- Willing to participate in the study, is expected to be compliant, able to cooperate with study procedures, and have a high probability of completing the study in the opinion of the investigator
- Vital sign results at Visit 1 and (pre-IP administration) at Visit 2 are within normal ranges, or if outside the normal ranges the results are judged by the investigator to not be clinically significant
- Karnofsky performance status 70 or better (ECOG 0, 1)
- Life expectancy of 6 months or more as judged by the investigator
- Patient is medically suitable for salvage therapies
Exclusion Criteria:
- Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components
- Prior PSMA PET scan within 6 months of enrolment
- Use of any other investigational medication or devices within 30 days prior to Visit 1
- Known allergies or sensitivity to any component of the investigational product used in this study
- Received significant ionizing radiation exposure, as judged by the Investigator, including from diagnostic or therapeutic radiopharmaceuticals used in clinical trials or for routine medical examinations, in the last 12 months
- Undergoing ongoing occupational monitoring for radiation exposure
- Clinically active, unstable, serious, life-threatening medical condition or disease that is, in the opinion of the Investigator, inadequately treated and/or where study participation may compromise the clinical management of the subject, or any other reason that makes the subject unsuitable to participate in this study
- The participant has a history of alcohol or substance abuse
- Patient cannot lie still for at least 30 minutes or comply with imaging procedure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: [18F]PSMA-1007 Injection
A single dose of 3 - 4 MBq/kg Body Weight (up to a maximum of 400 MBq) of [18F]PSMA-1007 Injection will be administered followed by PET/CT imaging.
(Patients on ADT treatment will receive the second dose approximately 6 months after the first dose)
|
a novel [18F] PSMA radiotracer that is highly selective for PSMA.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Endpoint:
Time Frame: 8 months
|
• Imaging concordance (sensitivity, specificity, PPV, NPV) will be calculated by comparing presence or absence of disease based on PSMA-PET (at the patient level) compared with clinical outcome information (e.g., conventional imaging, clinical outcome surrogate or histopathologic correlate)
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8 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety: Occurrence of AEs, SAEs, and changes from baseline in vital signs
Time Frame: 2 days
|
2 days
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Percentage of patients identified with recurrent disease using [18F]PSMA-1007
Time Frame: 2 months
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2 months
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Frequency with which [18F]PSMA-1007 PET/CT results lead to a change in recommended management
Time Frame: 2 months
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2 months
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of patients with detectable disease relative to PSA levels
Time Frame: 2 months
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2 months
|
Imaging concordance (sensitivity, specificity, PPV, NPV) based on [18F]PSMA-1007 PET/CT (at the regional level) compared with clinical outcome information (e.g., conventional imaging, clinical outcome surrogate or histopathologic correlate)
Time Frame: 8 months
|
8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 21, 2020
Primary Completion (Actual)
January 8, 2024
Study Completion (Actual)
January 8, 2024
Study Registration Dates
First Submitted
November 11, 2020
First Submitted That Met QC Criteria
November 24, 2020
First Posted (Actual)
November 25, 2020
Study Record Updates
Last Update Posted (Estimated)
February 7, 2024
Last Update Submitted That Met QC Criteria
February 5, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPD-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent Prostate Cancer
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National Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Matrix Biomed, Inc.Prostate Oncology SpecialistsNot yet recruitingProstate Cancer Recurrent | Biochemical Recurrent Prostate CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Prostate Cancer | Stage I Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Mayo ClinicNot yet recruitingRecurrent Prostate Cancer | Castration-resistant Prostate Cancer | Stage IVB Prostate Cancer AJCC v8 | Recurrent Castration-Sensitive Prostate CarcinomaUnited States
-
Mayo ClinicRecruitingBiochemically Recurrent Prostate Carcinoma | Stage IV Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Oligometastatic Prostate Carcinoma | Recurrent Prostate AdenocarcinomaUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
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University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on [18F] PSMA-1007 Injection
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University of AlbertaActive, not recruiting
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Primo Biotechnology Co., LtdABX advanced biochemical compounds GmbHRecruitingProstate Cancer | Prostate NeoplasmTaiwan
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First Hospital of China Medical UniversityRecruiting
-
University Hospital Inselspital, BerneActive, not recruiting
-
IRCCS San RaffaeleNot yet recruiting
-
University of AlbertaRecruiting
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Glenn BaumanUnited States Department of Defense; Western University, Canada; Centre for Probe...RecruitingProstate Cancer | Prostate Adenocarcinoma | Prostate NeoplasmCanada
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Radboud University Medical CenterUnknownGlioblastoma MultiformeNetherlands
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Radboud University Medical CenterABX advanced biochemical compounds GmbHActive, not recruiting
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Irene BurgerCompletedProstate CancerSwitzerland