Study to Evaluate the Safety and Efficacy of Switching From Zoladex® Monthly or Quarterly, to Eligard® Semiannual.

Last updated: March 21, 2022
Sponsor: Zodiac Produtos Farmaceuticos S.A.
Overall Status: Completed

Phase

4

Condition

Prostate Cancer, Early, Recurrent

Prostate Disorders

Prostate Cancer

Treatment

N/A

Clinical Study ID

NCT05304169
1500100
  • Ages > 18
  • Male

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient able to understand the process of the informed consent form (ICF);
  2. Male aged ≥18 years old;
  3. Having a histologically confirmed diagnosis of prostate adenocarcinoma;
  4. Having an indication of androgen deprivation treatment:
  5. Being on treatment with monthly or quarterly goserelin acetate depot formulationfor at least 3 months and for a maximum of 18 months OR;
  6. Having an indication to start treatment with quarterly goserelin acetate depotformulation.
  7. Patient with ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2;
  8. Patient with appropriate castration level, defined by a serum testosterone level ≤50ng/dL (≤1.73 nmol/L) demonstrated before V1.
  9. Appropriate hematologic function in the screening period: neutrophil count >1,500/μL,platelets >100,000/μL, hemoglobin >10 g/dL;
  10. Appropriate liver function in the screening period of the study: total serum bilirubin ≤1.5 x upper normal limit, AST (aspartate aminotransferase) or ALT (alanineaminotransferase) ≤40 U/L, alkaline phosphatase <130 U/L, gamma-GT (glutamyltransferase) <100 U/L;
  11. Appropriate kidney function in the screening period of the study: serum urea withinnormal limits for the method used at the institution, serum creatinine between 0.6 and 1.3 mg/dL, creatinine clearance calculated by the Cockroft- Gault formula > 40 mL/min;

Exclusion

Exclusion Criteria:

  1. Patients who did not have or do not have an indication for treatment with goserelinacetate;
  2. Patients with goserelin treatment for over 18 months;
  3. Patients who have received previous chemotherapy;
  4. Patient unable to follow the foreseen study visit schedule;
  5. Suspected or proven brain metastasis or active leptomeningeal disease;
  6. Uncontrolled arterial hypertension defined as systolic pressure ≥160 mmHg or diastolicpressure ≥95 mmHg;
  7. Long-term use of estrogen therapy or peripheral blockade;
  8. Another concomitant neoplasm;
  9. Any medical condition which, at the investigator's discretion, offers risk to thepatient's participation in the study;
  10. Having participated in another clinical study within less than 12 months.

Study Design

Total Participants: 48
Study Start date:
November 14, 2017
Estimated Completion Date:
June 15, 2020

Study Description

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).

Connect with a study center

  • CPMEC - Hospital Nossa Senhora da Conceição

    Porto Alegre, RS
    Brazil

    Site Not Available

  • HCB - Hospital do Câncer de Barretos

    Barretos, SP
    Brazil

    Site Not Available

  • Hospital Amaral Carvalho

    Jaú, SP
    Brazil

    Site Not Available

  • CIP - Centro Integrado de Pesquisa

    São José do Rio Preto, SP
    Brazil

    Site Not Available

  • ICESP - Instituto do Câncer do Estado de São Paulo

    São Paulo, SP
    Brazil

    Site Not Available

  • IAMSPE - Instituto de Assistência Médica ao Servidor Público Estadual de S. Paulo

    São Paulo,
    Brazil

    Site Not Available

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