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Prostate Cancer RecurrentPhase 3NCT04644822

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

A Phase 3 study testing [18F] PSMA-1007 Injection in people with Prostate Cancer Recurrent and Recurrent Prostate Cancer, run by Centre for Probe Development and Commercialization at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
[18F] PSMA-1007 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesCanada
Study dates
21 Dec 2020to 8 Jan 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

  • University Health Network - Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

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.

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).

Being tested
[18F] PSMA-1007 Injection
Keywords
prostate cancer, recurrent prostate cancer, persistent prostate cancer, PSMA, PET/CT, [18F]PSMA-1007
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F] PSMA-1007 InjectionDiagnostic test

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

Study groups in NCT04644822
Study groupRoleWhat they receive
[18F]PSMA-1007 InjectionExperimentalA 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)
Receives: Diagnostic Test: [18F] PSMA-1007 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Endpoint:

    • 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)

    Measured: 8 months

Secondary outcomes (3)

  1. Safety: Occurrence of AEs, SAEs, and changes from baseline in vital signs

    Measured: 2 days

  2. Percentage of patients identified with recurrent disease using [18F]PSMA-1007

    Measured: 2 months

  3. Frequency with which [18F]PSMA-1007 PET/CT results lead to a change in recommended management

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2020
  2. Study start21 Dec 2020
  3. Primary completion8 Jan 2024
  4. Study completion8 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04644822
Sponsor's protocol ID
CPD-002
Status last verified
Feb 2024
First submitted
11 Nov 2020
Last updated
7 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing [18F] PSMA-1007 Injection in people with Prostate Cancer Recurrent and Recurrent Prostate Cancer, run by Centre for Probe Development and Commercialization at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Endpoint: (time frame: 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04644822.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.

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