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Trial · Interventional

CompletedPhase 4Registry data

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

Short name PRIZE

NCTNCT05304169 (opens ClinicalTrials.gov in a new tab)Other id1500100
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
48 participants (actual)
Sponsor
Zodiac Produtos Farmaceuticos S.A. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Brazil

Start
14 Nov 2017
Primary completion
15 Jun 2018
Completion
15 Jun 2020
First posted
31 Mar 2022
Last update posted
31 Mar 2022
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20172018201920202021
  1. Ph 4

    PRIZE

    NCT05304169

    14 Nov 2017 to 15 Jun 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • Leuprorelin Acetate (Eligard® 45 mg).Drug

Arms1

  • Experimental

    Leuprorelin Acetate (Eligard® 45 mg)

    Patients received two subcutaneous injections of Eligard® 45 mg (leuprorelin acetate), with the first injection given at baseline (Visit 1) and the second after 168 ± 3 days at Visit 4.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Baseline testosterone levels (≤50 ng/dL)

    Time frame · One year of treatment

    Registry description

    Maintenance of baseline testosterone levels (≤50 ng/dL) after switching from goserelin acetate to leuprorelin acetate 45 mg (Eligard® 45 mg, Zodiac).

Secondary outcomes(6)

  1. Efficacy (consecutive PSA > 4 ng/mL)

    Time frame · One year of treatment

    Registry description

    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.

  2. Adverse events frequency (%)

    Time frame · One year of treatment

    Registry description

    Collection and descriptive analysis of adverse events.

  3. Number of Participants With Abnormal Laboratory Values (Number of participants)

    Time frame · One year of treatment

    Registry description

    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.

  4. Number of Participants With Abnormal Vital Signs (Number of participants)

    Time frame · One year of treatment

    Registry description

    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)

  5. Number of Participants With Abnormal Parameters for Quality of Life according to EORTC QLQ-C30 (Number of Participants)

    Time frame · One year of treatment

    Registry description

    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)

  6. Number of Participants With Abnormal Parameters for Quality of Life according to EORTC QLQ-PR25 (Number of participants)

    Time frame · One year of treatment

    Registry description

    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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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: 1. Being on treatment with monthly or quarterly goserelin acetate depot formulation for at least 3 months and for a maximum of 18 months OR; 2. Having an indication to start treatment with quarterly goserelin acetate depot formulation. 5. Patient with ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2; 6. Patient with appropriate castration level, defined by a serum testosterone level ≤50 ng/dL (≤1.73 nmol/L) demonstrated before V1. 7. Appropriate hematologic function in the screening period: neutrophil count \>1,500/μL, platelets \>100,000/μL, hemoglobin \>10 g/dL; 8. Appropriate liver function in the screening period of the study: total serum bilirubin ≤1.5 x upper normal limit, AST (aspartate aminotransferase) or ALT (alanine aminotransferase) ≤40 U/L, alkaline phosphatase \<130 U/L, gamma-GT (glutamyl transferase) \<100 U/L; 9. Appropriate kidney function in the screening period of the study: serum urea within normal 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 Criteria: 1. Patients who did not have or do not have an indication for treatment with goserelin acetate; 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 diastolic pressure ≥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 the patient's participation in the study; 10. Having participated in another clinical study within less than 12 months.

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