Prostate CancerPhase 4PRIZENCT05304169
Study to Evaluate the Safety and Efficacy of Switching From Zoladex® Monthly or Quarterly, to Eligard® Semiannual.
A Phase 4 study testing Leuprorelin Acetate (Eligard® 45 mg). in people with Prostate Cancer, run by Zodiac Produtos Farmaceuticos S.A. at 6 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Leuprorelin Acetate (Eligard® 45 mg).
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 6 sitesBrazil
- Study dates
- 14 Nov 2017to 15 Jun 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
HCB - Hospital do Câncer de Barretos
Barretos, São Paulo
Hospital Amaral Carvalho
Jaú, São Paulo
CPMEC - Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul
CIP - Centro Integrado de Pesquisa
São José do Rio Preto, São Paulo
ICESP - Instituto do Câncer do Estado de São Paulo
São Paulo, São Paulo
IAMSPE - Instituto de Assistência Médica ao Servidor Público Estadual de S. Paulo
São Paulo
About this study
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®)
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).
Read the 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).
- Conditions
- Prostate Cancer
- Being tested
- Leuprorelin Acetate (Eligard® 45 mg).
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leuprorelin Acetate (Eligard® 45 mg).Drug
Also called Leuprorelin Acetate
Semiannually Leuprorelin Acetate (Eligard® 45 mg).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Leuprorelin Acetate (Eligard® 45 mg). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: One year of treatment
Secondary outcomes (6)
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.
Measured: One year of treatment
Adverse events frequency (%)
Collection and descriptive analysis of adverse events.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: One year of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start14 Nov 2017
- Primary completion15 Jun 2018
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zodiac Produtos Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rafael Ferreira Coelho, Principal investigator, ICESP - Instituto do Câncer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304169
- Sponsor's protocol ID
- 1500100
- Acronym
- PRIZE
- Status last verified
- Mar 2022
- First submitted
- 11 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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®)
- ClinicalTrials.gov ID
- NCT05304169
- Acronym / sponsor ID
- PRIZE / 1500100
- Conditions
- Prostate Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Zodiac Produtos Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leuprorelin Acetate (Eligard® 45 mg) | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Patient with ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leuprorelin Acetate (Eligard® 45 mg).Also: Leuprorelin AcetateSemiannually Leuprorelin Acetate (Eligard® 45 mg). | Drug | Leuprorelin Acetate (Eligard® 45 mg) |
Primary outcome
Baseline testosterone levels (≤50 ng/dL)
Time frame: One year of treatment
Maintenance of baseline testosterone levels (≤50 ng/dL) after switching from goserelin acetate to leuprorelin acetate 45 mg (Eligard® 45 mg, Zodiac).
6 secondary outcomes
Efficacy (consecutive PSA > 4 ng/mL)
Time frame: One year of treatment
Adverse events frequency (%)
Time frame: One year of treatment
Number of Participants With Abnormal Laboratory Values (Number of participants)
Time frame: One year of treatment
Number of Participants With Abnormal Vital Signs (Number of participants)
Time frame: One year of treatment
Number of Participants With Abnormal Parameters for Quality of Life according to EORTC QLQ-C30 (Number of Participants)
Time frame: One year of treatment
Number of Participants With Abnormal Parameters for Quality of Life according to EORTC QLQ-PR25 (Number of participants)
Time frame: One year of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Ferreira Coelho principal investigator
ICESP - Instituto do Câncer do Estado de São Paulo
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Leuprorelin Acetate (Eligard® 45 mg). in people with Prostate Cancer, run by Zodiac Produtos Farmaceuticos S.A. at 6 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline testosterone levels (≤50 ng/dL) (time frame: One year of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.