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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Leuprorelin Acetate (Eligard® 45 mg).

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Patient able to understand the process of the informed consent form (ICF);
Male aged ≥18 years old;
Having a histologically confirmed diagnosis of prostate adenocarcinoma;
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.
Patient with ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2;
Patient with appropriate castration level, defined by a serum testosterone level ≤50 ng/dL (≤1.73 nmol/L) demonstrated before V1.
Appropriate hematologic function in the screening period: neutrophil count >1,500/μL, platelets >100,000/μL, hemoglobin >10 g/dL;
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;
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:

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

Sites / Locations

CPMEC - Hospital Nossa Senhora da Conceição
HCB - Hospital do Câncer de Barretos
Hospital Amaral Carvalho
CIP - Centro Integrado de Pesquisa
ICESP - Instituto do Câncer do Estado de São Paulo
IAMSPE - Instituto de Assistência Médica ao Servidor Público Estadual de S. Paulo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Leuprorelin Acetate (Eligard® 45 mg)

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Adverse events frequency (%)

Collection and descriptive analysis of adverse events.

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.

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)

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)

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

Full Information

NCT ID

NCT05304169

First Posted

March 11, 2022

Last Updated

March 21, 2022

Sponsor

Zodiac Produtos Farmaceuticos S.A.

1. Study Identification

Unique Protocol Identification Number

NCT05304169

Brief Title

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

Acronym

PRIZE

Official Title

PRospective, Multicenter Study to Evaluate Safety and Efficacy of Switching Treatments of Prostate Cancer Patients, Initially on Use of Monthly or Quarterly Goserelin Acetate (Zoladex®), to Semiannually Leuprorelin Acetate (Eligard®)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

November 14, 2017 (Actual)

Primary Completion Date

June 15, 2018 (Actual)

Study Completion Date

June 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zodiac Produtos Farmaceuticos S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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).

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Leuprorelin Acetate (Eligard® 45 mg)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Leuprorelin Acetate (Eligard® 45 mg).

Other Intervention Name(s)

Leuprorelin Acetate

Intervention Description

Semiannually Leuprorelin Acetate (Eligard® 45 mg).

Primary Outcome Measure Information:

Title

Baseline testosterone levels (≤50 ng/dL)

Description

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

Secondary Outcome Measure Information:

Title

Efficacy (consecutive PSA > 4 ng/mL)

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.

Time Frame

One year of treatment

Title

Adverse events frequency (%)

Description

Collection and descriptive analysis of adverse events.

Time Frame

One year of treatment

Title

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

Description

Time Frame

One year of treatment

Title

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

Description

Time Frame

One year of treatment

Title

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

Description

Time Frame

One year of treatment

Title

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

Description

Time Frame

One year of treatment

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient able to understand the process of the informed consent form (ICF); Male aged ≥18 years old; Having a histologically confirmed diagnosis of prostate adenocarcinoma; Having an indication of androgen deprivation treatment: Being on treatment with monthly or quarterly goserelin acetate depot formulation for at least 3 months and for a maximum of 18 months OR; Having an indication to start treatment with quarterly goserelin acetate depot formulation. Patient with ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2; Patient with appropriate castration level, defined by a serum testosterone level ≤50 ng/dL (≤1.73 nmol/L) demonstrated before V1. Appropriate hematologic function in the screening period: neutrophil count >1,500/μL, platelets >100,000/μL, hemoglobin >10 g/dL; 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; 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: Patients who did not have or do not have an indication for treatment with goserelin acetate; Patients with goserelin treatment for over 18 months; Patients who have received previous chemotherapy; Patient unable to follow the foreseen study visit schedule; Suspected or proven brain metastasis or active leptomeningeal disease; Uncontrolled arterial hypertension defined as systolic pressure ≥160 mmHg or diastolic pressure ≥95 mmHg; Long-term use of estrogen therapy or peripheral blockade; Another concomitant neoplasm; Any medical condition which, at the investigator's discretion, offers risk to the patient's participation in the study; Having participated in another clinical study within less than 12 months.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rafael Ferreira Coelho

Organizational Affiliation

ICESP - Instituto do Câncer do Estado de São Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

CPMEC - Hospital Nossa Senhora da Conceição

City

Porto Alegre

State/Province

Country

Brazil

Facility Name

HCB - Hospital do Câncer de Barretos

City

Barretos

State/Province

Country

Brazil

Facility Name

Hospital Amaral Carvalho

City

Jaú

State/Province

Country

Brazil

Facility Name

CIP - Centro Integrado de Pesquisa

City

São José do Rio Preto

State/Province

Country

Brazil

Facility Name

ICESP - Instituto do Câncer do Estado de São Paulo

City

São Paulo

State/Province

Country

Brazil

Facility Name

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

City

São Paulo

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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