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Prostate CancerPET-PSMANCT05169372

Retrospective Analysis of 68Ga-PSMA-PET in Patients With Prostate Cancer: Experience From Brazil

An observational study of Prostate Cancer, run by Latin American Cooperative Oncology Group at 3 sites in Brazil.

Terminated

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

Official record
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Trial summary

Gallium-68-prostate-specific membrane antigen (68Ga-PSMA) positron emission tomography (PET) has been increasingly used in the management of PCa in Brazil. Thus, the detection of metastatic lesions is improved over traditional methods e.g. MRI and the diagnosis of mCSPC patients has been proportionally increasing. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
How many people
12 participants
Where
3 sitesBrazil
Study dates
11 May 2022to 19 Jan 2024
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: Patients with localized or biochemical recurrence prostate cancer with no detection of extra-prostatic disease in traditional imaging (bone scan and abdominal and pelvic CT or MRI) who underwent 68Ga-PSMA-PET imaging between October 2015 and January 202.

Who may be able to join

  • Age of at least 18 years at study entry;
  • Histologically confirmed adenocarcinoma of the prostate;
  • 68Ga-PSMA-PET exam performed between October 2015 and January 2021;
  • 68Ga-PSMA-PET performed in one of the following situations:
  • localized disease at diagnosis in patients with no detection of extra-prostatic disease in traditional imaging such as CT scan, MRI and bone scan;
  • biochemical recurrence (according to PCWG3 or defined by the investigator) in patients with no detection of prostatic or extra-prostatic disease in traditional imaging such as CT scan, MRI and bone scan;
  • Traditional imaging (pelvic and abdominal CT or MRI and bone scan) with negative results (no extra-prostatic disease, for localized and biochemical recurrence disease; no prostatic for biochemical recurrence disease) performed within 8 weeks before 68Ga-PSMA-PET;
  • Site and investigator ability to collect adequate patient characteristics, treatment and outcome data from medical records.

Who cannot join

  • Patients with no disease characteristics accessible in medical records;
  • Cancer diagnosis other than prostate cancer in the last 5 years;
  • Disease detected by traditional imaging techniques (bone scan, CT and/or MRI), meaning extra-prostatic disease, for localized and biochemical recurrence disease; or prostatic disease for biochemical recurrence disease.

Trial locations and contacts

3 sites in 1 country.

Brazil3 sites

  • HMV - Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90.035-000

  • CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90.610-000

  • Instituto COI - Clínicas Oncológicas Integradas (Instituto Américas RJ)

    Rio de Janeiro, 22.793-080

Other trials in Brazil

About this study

Gallium-68-prostate-specific membrane antigen (68Ga-PSMA) positron emission tomography (PET) has been increasingly used in the management of PCa in Brazil. Thus, the detection of metastatic lesions is improved over traditional methods e.g. MRI and the diagnosis of mCSPC patients has been proportionally increasing. Due to a lack of guidelines and clinical trials including 68Ga-PSMA-PET imaging, the management of these patients is extrapolated from data based on conventional imaging. Treatment decision and duration of treatment for mCSPC patients based on 68Ga-PSMA-PET imaging is currently unknown. 68Ga-PSMA-PET allows a diagnosis of a different set of low volume oligo-metastatic prostate cancer patients. Based on that, a new gap has been built up, since there are no standards of how those patients are managed and how they respond to conventional therapies, to metastasis direct therapy or even if they could be spared of any treatment, reducing costs and toxicities. This patient population has not been included in clinical trials and its critical to generate information on the diagnosis, treatment and outcome of these patients in clinical practice.

Conditions
Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What is being measured

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

  1. The rate of patients with 68Ga-PSMA-PET positive lesions

    The rate of patients with 68Ga-PSMA-PET positive lesions [defined as the presence of lesions with 68Ga-PSMA uptake in the prostate (biochemical recurrence) and in extra-prostatic sites (localized disease and biochemical recurrence) in patients with no detected lesions in conventional imaging (no extra prostatic disease, for localized and biochemical recurrence disease; or prostatic disease for biochemical recurrence disease)]

    Measured: January 2021

Secondary outcomes (6)

  1. 68Ga-PSMA-PET prostate cancer confirmed detection rate

    Defined as the proportion of patients with prostate cancer confirmed by histopathology or with PSA response (reduction ≥ 50% on PSA levels from baseline) in those treated with lesion-directed therapy without ADT in day + 90)

    Measured: January 2021

  2. Treatment patterns in evaluable patients based on 68Ga-PSMA-PET diagnostic status

    Measured: January 2021

  3. The percentage of change in initial treatment plan considering the results of 68Ga-PSMA-PET in negative traditional imaging

    Measured: January 2021

  4. To describe the type of disease monitoring imaging technique (i.e., CT scan, MRI, 68Ga-PSMA-PET) methods after initial diagnosis with 68Ga-PSMA-PET

    Measured: January 2021

  5. Clinical effectiveness of first-line treatment based on 68Ga-PSMA-PET diagnostic status

    (no extra-prostatic disease - localized disease or local recurrence); nodal positive/metastasis negative (regional disease) and metastasis positive (distant disease)

    Measured: January 2021

  6. Treatment duration of first-line treatment based on 68Ga-PSMA-PET diagnostic status

    Measured: January 2021

Timeline

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

  1. First posted23 Dec 2021
  2. Study start11 May 2022
  3. Primary completion19 Jan 2024
  4. Study completion19 Jan 2024

Why it stopped: LACOG and Astellas decided to end the study due to the great difficulty in finding patients with the desired profile.

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
Retrospective
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05169372
Sponsor's protocol ID
LACOG 0121
Acronym
PET-PSMA
Status last verified
Feb 2024
First submitted
20 Dec 2021
Last updated
21 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?

An observational study of Prostate Cancer, run by Latin American Cooperative Oncology Group at 3 sites in Brazil.

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 8 inclusion and 3 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 21 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 3 sites in Brazil. 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: LACOG and Astellas decided to end the study due to the great difficulty in finding patients with the desired profile.). 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?

The rate of patients with 68Ga-PSMA-PET positive lesions (time frame: January 2021). 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 NCT05169372.

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 21 Feb 2024.

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