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Prostate CancerNCT05709535

PSMA-PET/CT Registry

An observational study of Prostate Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a prospective registry study to evaluate the diagnostic utility of [18F]-PSMA-1007 (PSMA-PET/CT) to stage patients with high-risk prostate cancer, localize sites of biochemical recurrence of prostate cancer, and restage patients with advanced prostate cancer before onset of new therapy. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
[18F]-PSMA-1007
Type of treatment
Injection or infusion
How many people
128 participants
Where
1 siteCanada
Study dates
11 Jul 2023to 1 Nov 2024
How long will I take part?
1 Year
Phase
Observational
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

Study population: High-Risk, Biochemically Relapsed, and Advanced Prostate Cancer

Who may be able to join

  • Study participant has provided informed consent prior to initiation of any study specific activities/procedures.
  • Age greater than or equal to 18 years.
  • Subjects with histological diagnosis of prostate cancer.
  • Subjects with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Subjects with biochemical recurrence or persistence of prostate cancer following initial curative treatment by radical prostatectomy, with two consecutive PSA values >0.2 ng/ml measured more than 6 weeks after radical prostatectomy. If subjects received subsequent systemic therapy, the most recent PSA measurement prior to PET/CT imaging must be greater than 0.2 ng/mL OR
  • Subjects with biochemical recurrence or persistence of prostate cancer following initial curative treatment by radical prostatectomy and subsequently treated by salvage radiotherapy or pelvic node dissection, with two consecutive PSA values >0.2 ng/ml. If subjects received subsequent systemic therapy, the most recent PSA measurement prior to PET/CT imaging must be greater than 0.2 ng/mL OR
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  • Subjects with biochemical recurrence of prostate cancer after initial curative therapy with radiation therapy (including brachytherapy), or non-standard local ablative therapy (such as high frequency ultrasound, cryoablation, focal laser ablation, etc.), with a PSA level >2 ng/mL above the nadir after radiation therapy OR
  • Subjects with advanced castration sensitive or castration resistant prostate cancer being considered for localized treatment (surgery, brachytherapy, radiotherapy) of recurrent or oligometastatic prostate cancer. Castration resistance is defined as a PSA level > 1.0 ng/mL, with 2 consecutive rises above the nadir, in the presence of castrate levels of testosterone (< 1.7 nmol/L) OR
  • Subjects with metastatic or castration resistant prostate cancer being evaluated for systemic therapy administered in therapeutic clinical trials. The PSA level must be > 1.0 ng/mL, with 2 consecutive rises above the nadir, in the presence of castrate levels of testosterone (< 1.7 nmol/L) OR
  • Subjects with high-risk prostate cancer, defined as T3a, Gleason ≥8, or PSA ≥20, and "very high risk" as T3b or T4 disease.
  • Patients of childbearing potential must adhere to the contraception requirement from screening throughout the study period up to 90 days after the last dose of study intervention.

Who cannot join

  • Unable to lie supine for the duration of imaging.
  • Unable to provide written consent.
  • Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm).
  • Lack of IV access.
  • History of allergic reaction to [18F]-PSMA-1007.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta

Other trials in Canada

About this study

Official title: PSMAN: POET PSMA-PET/CT Registry for High-Risk, Biochemically Relapsed, and Advanced Prostate Cancer

This is a prospective registry study to evaluate the diagnostic utility of [18F]-PSMA-1007 (PSMA-PET/CT) to stage patients with high-risk prostate cancer, localize sites of biochemical recurrence of prostate cancer, and restage patients with advanced prostate cancer before onset of new therapy.

Read the detailed description

Prostate cancer is the most common non-skin malignancy and the third leading cause of cancer death in Canadian men. High-risk, recurrent, and metastatic prostate cancer is associated with poor patient outcomes. It is highly possible that the inability to accurately detect disease earlier in these patients is a key limiting factor in effectively treating patients with advanced prostate cancer.

Prostate specific membrane antigen (PSMA) is seen on many patients' prostate cancer tumours, and that PSMA expression can not only help detect cancer earlier, but it can also help determine how to treat patients with both standard treatments (e.g., surgery or radiation), as well as systemic new medical treatments (e.g. [177Lu]-PSMA-617). The new imaging technology, PSMA PET/CT, has been shown to be more sensitive and specific for the detection of metastatic prostate cancer than the current standard of care imaging (CT and bone scan) and is starting to make its way into clinical use worldwide, but is not yet available outside of clinical trials in Canada.

In recent years, prostate-specific membrane antigen (PSMA, glutamate carboxypeptidase II) has gained a resurgence of interest as a powerful imaging biomarker in prostate cancer. PSMA has been labelled with several single positron emission computed tomography (SPECT) and PET radiotracers to radiographically detect and stage the extent of disease in prostate cancer. This registry study will provide Alberta centres access to a new PET tracer, [18F]-PSMA-1007. A prospective registry study of PSMA PET/CT to guide therapy will allow enhanced access to PSMA-PET/CT and examine its effectiveness in characterizing patterns of extent, staging recurrence, and/or metastasis of high-risk prostate cancer, and to personalize therapies in men with prostate cancer. The aim is to determine the proportion of PSMA-PET/CT imaging with positive findings at local, regional, or distant sites.

Conditions
Prostate Cancer
Being tested
[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-1007Diagnostic test

    [18F]PSMA-1007 is a diagnostic radiopharmaceutical for Positron Emission Tomography (PET) scan. The intervention involves single intravenous administration of [18F]PSMA-1007 for PET scan.

Study groups in NCT05709535
Study groupRoleWhat they receive
Experimental: [18F]PSMA-1007 InjectionA single intravenous dose of 3 - 4 MBq/kg (up to a maximum of 400 MBq) of [18F]PSMA-1007 Injection will be administered followed by PET/CT imaging.
Receives: Diagnostic Test: [18F]-PSMA-1007

What is being measured

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

  1. To determine the proportion of PSMA-PET/CT imaging with positive findings at local, regional, or distant sites, utilizing a new Positron Emission Tomography (PET) tracer, [18F]-PSMA-1007 (PSMA-PET/CT).

    The proportion of PSMA-PET/CT imaging with positive findings (whether at local, regional, or distant sites).

    Measured: 1 year

Secondary outcomes (2)

  1. To assess the predictive value of PSMA-PET/CT imaging on patient outcomes (e.g., radiographic/PSA progression free survival).

    A measure such as progression-free survival in relation to subsequent oncologic treatments to assess the impact of PSMA-PET/CT imaging on patient outcomes will be calculated.

    Measured: 1 year

  2. To assess the predictive value of PSMA-PET/CT imaging on patient outcomes (e.g., PSA response).

    A measure such as best response in relation to subsequent oncologic treatments to assess the impact of PSMA-PET/CT imaging on patient outcomes will be calculated.

    Measured: 1 year

Timeline

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

  1. First posted2 Feb 2023
  2. Study start11 Jul 2023
  3. Primary completion1 Nov 2024
  4. Study completion1 Nov 2024

Why it stopped: Not due to a safety concern; terminated early due to changing clinical trial landscape at centre

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
128 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT05709535
Sponsor's protocol ID
PSMA-PET-1007
Status last verified
Dec 2024
First submitted
19 Jan 2023
Last updated
18 Dec 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?

An observational study of Prostate Cancer, run by AHS Cancer Control Alberta at 1 site 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 11 inclusion and 5 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: stopped early, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

The study was stopped early (reason given: Not due to a safety concern; terminated early due to changing clinical trial landscape at centre). Results are not available in the source record.

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?

To determine the proportion of PSMA-PET/CT imaging with positive findings at local, regional, or distant sites, utilizing a new Positron Emission Tomography (PET) tracer, [18F]-PSMA-1007 (PSMA-PET/CT). (time frame: 1 year). 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 NCT05709535.

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 18 Dec 2024.

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