Clinical trial NCT05169372: Retrospective Analysis of 68Ga-PSMA-PET in Patients With Prostate Cancer: Experience From Brazil
Official title: Retrospective Analysis of 68Ga-PSMA-PET in Patients With Prostate Cancer: Experience From Brazil
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Lead sponsor: Latin American Cooperative Oncology Group
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2021-12-23
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: The rate of patients with 68Ga-PSMA-PET positive lesions
timeFrame: January 2021
Secondary outcomes:
measure: 68Ga-PSMA-PET prostate cancer confirmed detection rate
timeFrame: January 2021
measure: Treatment patterns in evaluable patients based on 68Ga-PSMA-PET diagnostic status
timeFrame: January 2021
measure: The percentage of change in initial treatment plan considering the results of 68Ga-PSMA-PET in negative traditional imaging
timeFrame: January 2021
measure: 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
timeFrame: January 2021
measure: Clinical effectiveness of first-line treatment based on 68Ga-PSMA-PET diagnostic status
timeFrame: January 2021
measure: Treatment duration of first-line treatment based on 68Ga-PSMA-PET diagnostic status
timeFrame: January 2021
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: HMV - Hospital Moinhos de Vento
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS
state: Rio Grande Do Sul
city: Rio De Janeiro
country: Brazil
facility: Instituto COI - Clínicas Oncológicas Integradas (Instituto Américas RJ)
Study officials:
affiliation: Latin American Cooperative Oncology Group
name: Andrey Soares
role: PRINCIPAL_INVESTIGATOR
References: