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

NCT05304169 | Completed Phase 4

• 1 other identifier: 1500100
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 6

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).

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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).

  One year of treatment

Secondary Outcomes (6)

• Efficacy (consecutive PSA > 4 ng/mL)

  One year of treatment

• Adverse events frequency (%)

  One year of treatment

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

  One year of treatment

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

  One year of treatment

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

  One year of treatment

Study Arms (1)

Leuprorelin Acetate (Eligard® 45 mg)

EXPERIMENTAL

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.

Drug: Leuprorelin Acetate (Eligard® 45 mg).

Interventions

Leuprorelin Acetate (Eligard® 45 mg). DRUG

Semiannually Leuprorelin Acetate (Eligard® 45 mg).

Also known as: Leuprorelin Acetate

Leuprorelin Acetate (Eligard® 45 mg)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zodiac Produtos Farmaceuticos S.A.: lead

Study Sites (6)

CPMEC - Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, Brazil

Location

HCB - Hospital do Câncer de Barretos

Barretos, São Paulo, Brazil

Location

Hospital Amaral Carvalho

Jaú, São Paulo, Brazil

Location

CIP - Centro Integrado de Pesquisa

São José do Rio Preto, São Paulo, Brazil

Location

ICESP - Instituto do Câncer do Estado de São Paulo

São Paulo, São Paulo, Brazil

Location

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

São Paulo, Brazil

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Leuprolide; luprolide acetate gel depot

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Rafael Ferreira Coelho

  ICESP - Instituto do Câncer do Estado de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 31, 2022
• Study Start: November 14, 2017
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2020
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (6)