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

NCT05169372 | Terminated

• 1 other identifier: LACOG 0121
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

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

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

  January 2021

Secondary Outcomes (6)

• 68Ga-PSMA-PET prostate cancer confirmed detection rate

  January 2021

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

  January 2021

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

  January 2021

• 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

  January 2021

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

  January 2021

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Age of at least 18 years at study entry;
• Histologically confirmed adenocarcinoma of the prostate;
• Ga-PSMA-PET exam performed between October 2015 and January 2021;
• Ga-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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Latin American Cooperative Oncology Group: lead
• Astellas Pharma Inc: collaborator

Study Sites (3)

HMV - Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90.035-000, Brazil

Location

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

Porto Alegre, Rio Grande do Sul, 90.610-000, Brazil

Location

Instituto COI - Clínicas Oncológicas Integradas (Instituto Américas RJ)

Rio de Janeiro, 22.793-080, Brazil

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Andrey Soares

  Latin American Cooperative Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: December 23, 2021
• Study Start: May 11, 2022
• Primary Completion: January 19, 2024
• Study Completion: January 19, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (3)