Safety and Efficacy of [18F]PSMA-1007 Injection in Suspected Persistent or Recurrent Prostate Cancer.

Sponsor

Centre for Probe Development and Commercialization (Other)

Overall Status

Recruiting

CT.gov ID

NCT04644822

Collaborator

McDougall Scientific Ltd. (Other)

100

Enrollment

Locations

Arm

18.3

Anticipated Duration (Months)

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Recurrent Recurrent Prostate Cancer	Diagnostic Test: [18F] PSMA-1007 Injection	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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.

Actual Study Start Date :

Dec 21, 2020

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

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)	Diagnostic Test: [18F] PSMA-1007 Injection a novel [18F] PSMA radiotracer that is highly selective for PSMA.

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)

Diagnostic Test: [18F] PSMA-1007 Injection

a novel [18F] PSMA radiotracer that is highly selective for PSMA.

Outcome Measures

Primary Outcome Measures

Primary Endpoint: [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)

Secondary Outcome Measures

Safety: Occurrence of AEs, SAEs, and changes from baseline in vital signs [2 days]
Percentage of patients identified with recurrent disease using [18F]PSMA-1007 [2 months]
Frequency with which [18F]PSMA-1007 PET/CT results lead to a change in recommended management [2 months]

Other Outcome Measures

Percentage of patients with detectable disease relative to PSA levels [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) [8 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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