The purpose of this study is to evaluate the efficacy, quality of life and safety of switching from monthly (3.6 mg) or quarterly (10.8 mg) goserelin acetate (Zoladex®) to semiannual leuprorelin acetate 45 mg (Eligard® 45 mg) in prostate cancer patients with adequate hormonal castration level (plasma testosterone levels ≤50 ng/dL).
When systemic treatment is indicated, androgen deprivation therapy is the standard treatment for patients with prostate cancer. This condition occurs when the patient is diagnosed with metastatic disease or disseminated disease based on PSA values.The exchange of androgen hormone deprivation therapies in patients with metastatic prostate cancer may be required in different situations in clinical practice, such as: lack of medication available at the institution or on the market; alteration of the clinical protocol of the health institution due to economic factors and/or aiming to gain adherence to the treatment, often related to the posological convenience and/or logistics necessary for the administration of the medication, among others. Additionally, although there is evidence on the efficacy and safety of switching hormone treatments in patients with prostate cancer clinical data on this type of management of patients in Brazil are scarce. There are no data on how the management and switching of treatments is approached, nor on the clinical outcomes related to such a switch of therapy (time to progression, treatments used in combination with androgen deprivation therapy, time to onset of disease symptoms, time to start chemotherapy and costs involved).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Semiannually Leuprorelin Acetate (Eligard® 45 mg).
CPMEC - Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, Brazil
HCB - Hospital do Câncer de Barretos
Barretos, São Paulo, Brazil
Hospital Amaral Carvalho
Jaú, São Paulo, Brazil
CIP - Centro Integrado de Pesquisa
São José do Rio Preto, São Paulo, Brazil
Baseline testosterone levels (≤50 ng/dL)
Maintenance of baseline testosterone levels (≤50 ng/dL) after switching from goserelin acetate to leuprorelin acetate 45 mg (Eligard® 45 mg, Zodiac).
Time frame: One year of treatment
Efficacy (consecutive PSA > 4 ng/mL)
Disease progression rate from visit 2, defined as 3 consecutive elevations of PSA levels (with PSA \> 4 ng/mL) and/or new clinical evidence of disease.
Time frame: One year of treatment
Adverse events frequency (%)
Collection and descriptive analysis of adverse events.
Time frame: One year of treatment
Number of Participants With Abnormal Laboratory Values (Number of participants)
Determination of the number of participants with abnormal laboratory values defined at discretion of the principal investigator according to reference values. Evaluation of hematologic, kidney and liver function.
Time frame: One year of treatment
Number of Participants With Abnormal Vital Signs (Number of participants)
Determination of the number of participants with abnormal vital signs defined at discretion of the principal investigator, according to reference values. Evaluation of vital signs (e.g. electrocardiogram, blood pressure, pulse)
Time frame: One year of treatment
Number of Participants With Abnormal Parameters for Quality of Life according to EORTC QLQ-C30 (Number of Participants)
Determination of the number of participants with abnormal parameters for quality of life at discretion of the principal investigator. Quality of life was evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
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ICESP - Instituto do Câncer do Estado de São Paulo
São Paulo, São Paulo, Brazil
IAMSPE - Instituto de Assistência Médica ao Servidor Público Estadual de S. Paulo
São Paulo, Brazil
Time frame: One year of treatment
Number of Participants With Abnormal Parameters for Quality of Life according to EORTC QLQ-PR25 (Number of participants)
Determination of the number of participants with abnormal parameters for quality of life at discretion of the principal investigator. Quality of life was evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-PR25)
Time frame: One year of treatment