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

NCT ID: NCT05169372

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-11
• Study Completion Date: 2024-01-19

Brief 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. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Age of at least 18 years at study entry;

2. Histologically confirmed adenocarcinoma of the prostate;

3. 68Ga-PSMA-PET exam performed between October 2015 and January 2021;

4. 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;

5. 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;

6. Site and investigator ability to collect adequate patient characteristics, treatment and outcome data from medical records.

Exclusion Criteria

1. Patients with no disease characteristics accessible in medical records;

2. Cancer diagnosis other than prostate cancer in the last 5 years;

3. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: collaborator

Latin American Cooperative Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrey Soares

Role: PRINCIPAL_INVESTIGATOR

Latin American Cooperative Oncology Group

Locations

HMV - Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

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

Porto Alegre, Rio Grande do Sul, Brazil

Instituto COI - Clínicas Oncológicas Integradas (Instituto Américas RJ)

Rio de Janeiro, , Brazil

Countries

Brazil

Other Identifiers

LACOG 0121

Identifier Type: -

Identifier Source: org_study_id