Prostate Cancer Metastatic DiseaseLODENCT06718647
Efficacy and Tolerability of Low-Dose Enzalutamide in Prostate Cancer
An observational study of Prostate Cancer Metastatic Disease, run by Monica Boitano at 1 site in Italy.
Trial summary
Prostate cancer is the most common cancer in men in the United States and the second leading cause of cancer-related mortality in males. Since 2014, its incidence has increased by 3% annually, primarily due to a rise in advanced-stage cases. In Italy, over 41.000 cases were diagnosed in 2023, with 8.200 deaths. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Metastatic Disease
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population will consist of male patients aged 18 years or older with a histopathological diagnosis of metastatic prostate cancer who received Enzalutamide between 01/08/2014 and 31/12/2023.
Who may be able to join
- Patients with histological diagnosis metastatic prostate cancer;
- Enzalutamide therapy taken between 01/08/2014 and 31/12/2023;
- Age ≥ 18 years;
- Signed Informed consent.
Who cannot join
- Clinically significant cardiovascular disease for example cerebrovascular accidents (<=6 months), myocardial infarction (<=3 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF); uncontrolled hypertension or bradycardia
- Patients who died within one month of starting treatment with Enzalutamide for all causes;
- Uncontrolled concomitant diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Ente Ospedaliero Ospedali Galliera
Genoa, GENOA, 16128
Martino Oliva, +390105634506, martino.oliva@galliera.it
About this study
Official title: Efficacy and Tolerability of Low-Dose Versus Standard-Dose Enzalutamide in Advance Prostate Cancer: a Real-World Evidence Study
Prostate cancer is the most common cancer in men in the United States and the second leading cause of cancer-related mortality in males. Since 2014, its incidence has increased by 3% annually, primarily due to a rise in advanced-stage cases. In Italy, over 41.000 cases were diagnosed in 2023, with 8.200 deaths. Enzalutamide, an androgen receptor inhibitor, is effective in treating metastatic prostate cancer but often requires dose reductions to improve tolerability in frail patients. Recent studies have shown that lower doses (≤ 80 mg per day) can maintain efficacy while improving safety and tolerability, with outcomes comparable to the standard dose (160 mg per day) in terms of overall survival, progression-free survival, and prostate-specific antigen response.
Based on the results observed in these studies, the investigators expect that in our retrospective cohort of patients with metastatic prostate cancer, those who received low doses of enzalutamide will have a 1 year progression-free survival comparable to the full dose. The investigators will also expect a lower rate of adverse events.
Read the detailed description
Prostate cancer is the most frequent cancer in males in the United States, with 299.000 new cases estimated in 2024, and it is the second leading cause of cancer-related death in men. Since 2014, the prostate cancer incidence rate has risen by 3% per year, mostly driven by 4-5% per year increases for regional-stage and distant-stage diagnoses that began as early as 2011. Localized-stage disease also increased from 73.5 per 100.000 in 2014 to 84.8 per 100.000 in 2019, although the trend is not yet statistically significant. A recent study estimated that more than one half of men in the United States living with metastatic prostate cancer were initially diagnosed with localized or regional stage disease. In Italy, there were more than 41.000 diagnosed cases in 2023 and 8.200 deaths, accounting for nearly one-fifth of all cancers detected in men, and over 560.000 prevalent cases of men living with prostate.
Enzalutamide is a new generation oral androgen-receptor selective inhibitor that induces tumor regression and growth suppression in patients with metastatic prostate cancer. It is effective and well tolerated, compared with other anticancer drugs (ex-chemotherapy), but in real practice, very often in patients with comorbidity or poor performance status is necessary reduce the dose to reduce fatigue or other adverse events.
The standard recommended dosage of 160 mg per day has multiple side effects and dose reductions are often required.
Several randomized studies have underscored the importance of enzalutamide in treating prostate cancer. Initially approved by the Food and Drug Administration in 2012 for patients with metastatic castration-resistant prostate cancer who had previously received docetaxel, its indications were updated in October 2020 to include patients with castration-resistant prostate cancer experiencing biochemical relapse, or with metastatic castration-sensitive prostate cancer.
In phase I study enzalutamide (MDV3100) was administered with dose between 30 and 600 mg per day. There was a linear increase in steady state serum concentration with dose, but antitumor effects were observed at all doses, including 40-60 mg per day. The severity of treatment related adverse effects including fatigue and neurological disorders was associated with drug dose.
Recent data suggest its efficacy may be retained at lower doses with significant improvement in safety and tolerability. In two previously observational studies, in metastatic prostate cancer low-dose enzalutamide (≤ 80 mg per day) compared to standard dose (160 mg per day) did not show difference in overall survival and prostate-specific antigen progression-free survival. Interestingly, there was a trend towards a better prostate-specific antigen response and a significantly longer life among the low-dose group.
- Conditions
- Prostate Cancer Metastatic Disease
- Keywords
- Enzalutamide, Low-Doses, Prostatic neoplasms, Elderly, Adverse event, Metastatic prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose of Enzalutamide | Low Dose of Enzalutamide: ≤ 50% of the standard dose | |
| Intermediate Dose of Enzalutamide | Intermediate Dose of Enzalutamide: > 50% and ≤ 80% of the standard dose | |
| High Dose of Enzalutamide | High Dose of Enzalutamide: > 80% of the standard dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
The primary objective of this retrospective observational study is to evaluate whether low or intermediate doses of enzalutamide are comparable to the full dose in terms of 1-year average progression free survival time from the start of treatment, considering the event as the pathological progression of the disease.
Measured: 1 year
Adverse events
To evaluate the rate of adverse events worsening between low, intermediate and full dose groups. As adverse events, fatigue, hypertension and neurological disorders will be assessed as adverse events of special interest.
Measured: At end of treatment with Enzalutamide
Secondary outcomes (3)
Overall Survival
To evaluate the Overall Survival, in terms of 1 year average survival time from the start of treatment, between low or intermediate doses compared to full dose;
Measured: 1 year
Overall Survival
To evaluate the Overall Survival (OS), in terms of 3-years average survival time from the start of treatment, between low or intermediate doses compared to full dose;
Measured: 3 years
Prostate Specific Antigen response
To evaluate the Prostate Specific Antigen response at 12 weeks between groups.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Metastatic DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monica Boitano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Monica Boitano, Ente Ospedaliero Ospedali Galliera
- Investigators
- Andrea De Censi, Study chair, Ente Ospedaliero Ospedali Galliera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718647
- Sponsor's protocol ID
- LODE
- Acronym
- LODE
- Status last verified
- Jul 2025
- First submitted
- 2 Dec 2024
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- 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 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Low-Dose Versus Standard-Dose Enzalutamide in Advance Prostate Cancer: a Real-World Evidence Study
- ClinicalTrials.gov ID
- NCT06718647
- Acronym / sponsor ID
- LODE / LODE
- Conditions
- Prostate Cancer Metastatic Disease
- Keywords
- Enzalutamide, Low-Doses, Prostatic neoplasms, Elderly, Adverse event, Metastatic prostate cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Monica BoitanoUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Dec 2024 (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.
Prostate cancer is the most common cancer in men in the United States and the second leading cause of cancer-related mortality in males. Since 2014, its incidence has increased by 3% annually, primarily due to a rise in advanced-stage cases. In Italy, over 41.000 cases were diagnosed in 2023, with 8.200 deaths. Enzalutamide, an androgen receptor inhibitor, is effective in treating metastatic prostate cancer but often requires dose reductions to improve tolerability in frail patients. Recent studies have shown that lower doses (≤ 80 mg per day) can maintain efficacy while improving safety and tolerability, with outcomes comparable to the standard dose (160 mg per day) in terms of overall survival, progression-free survival, and prostate-specific antigen response.
Based on the results observed in these studies, the investigators expect that in our retrospective cohort of patients with metastatic prostate cancer, those who received low doses of enzalutamide will have a 1 year progression-free survival comparable to the full dose. The investigators will also expect a lower rate of adverse events.
Detailed description
Prostate cancer is the most frequent cancer in males in the United States, with 299.000 new cases estimated in 2024, and it is the second leading cause of cancer-related death in men. Since 2014, the prostate cancer incidence rate has risen by 3% per year, mostly driven by 4-5% per year increases for regional-stage and distant-stage diagnoses that began as early as 2011. Localized-stage disease also increased from 73.5 per 100.000 in 2014 to 84.8 per 100.000 in 2019, although the trend is not yet statistically significant. A recent study estimated that more than one half of men in the United States living with metastatic prostate cancer were initially diagnosed with localized or regional stage disease. In Italy, there were more than 41.000 diagnosed cases in 2023 and 8.200 deaths, accounting for nearly one-fifth of all cancers detected in men, and over 560.000 prevalent cases of men living with prostate.
Enzalutamide is a new generation oral androgen-receptor selective inhibitor that induces tumor regression and growth suppression in patients with metastatic prostate cancer. It is effective and well tolerated, compared with other anticancer drugs (ex-chemotherapy), but in real practice, very often in patients with comorbidity or poor performance status is necessary reduce the dose to reduce fatigue or other adverse events.
The standard recommended dosage of 160 mg per day has multiple side effects and dose reductions are often required.
Several randomized studies have underscored the importance of enzalutamide in treating prostate cancer. Initially approved by the Food and Drug Administration in 2012 for patients with metastatic castration-resistant prostate cancer who had previously received docetaxel, its indications were updated in October 2020 to include patients with castration-resistant prostate cancer experiencing biochemical relapse, or with metastatic castration-sensitive prostate cancer.
In phase I study enzalutamide (MDV3100) was administered with dose between 30 and 600 mg per day. There was a linear increase in steady state serum concentration with dose, but antitumor effects were observed at all doses, including 40-60 mg per day. The severity of treatment related adverse effects including fatigue and neurological disorders was associated with drug dose.
Recent data suggest its efficacy may be retained at lower doses with significant improvement in safety and tolerability. In two previously observational studies, in metastatic prostate cancer low-dose enzalutamide (≤ 80 mg per day) compared to standard dose (160 mg per day) did not show difference in overall survival and prostate-specific antigen progression-free survival. Interestingly, there was a trend towards a better prostate-specific antigen response and a significantly longer life among the low-dose group.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose of Enzalutamide | – | –Low Dose of Enzalutamide: ≤ 50% of the standard dose |
| Intermediate Dose of Enzalutamide | – | –Intermediate Dose of Enzalutamide: > 50% and ≤ 80% of the standard dose |
| High Dose of Enzalutamide | – | –High Dose of Enzalutamide: > 80% of the standard dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of male patients aged 18 years or older with a histopathological diagnosis of metastatic prostate cancer who received Enzalutamide between 01/08/2014 and 31/12/2023.
Key inclusion criteria (4 listed)
- Patients with histological diagnosis metastatic prostate cancer;
- Enzalutamide therapy taken between 01/08/2014 and 31/12/2023;
- Age ≥ 18 years;
- Signed Informed consent.
Key exclusion criteria (3 listed)
- Clinically significant cardiovascular disease for example cerebrovascular accidents (<=6 months), myocardial infarction (<=3 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF); uncontrolled hypertension or bradycardia
- Patients who died within one month of starting treatment with Enzalutamide for all causes;
- Uncontrolled concomitant diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression Free Survival
Time frame: 1 year
The primary objective of this retrospective observational study is to evaluate whether low or intermediate doses of enzalutamide are comparable to the full dose in terms of 1-year average progression free survival time from the start of treatment, considering the event as the pathological progression of the disease.
Adverse events
Time frame: At end of treatment with Enzalutamide
To evaluate the rate of adverse events worsening between low, intermediate and full dose groups. As adverse events, fatigue, hypertension and neurological disorders will be assessed as adverse events of special interest.
3 secondary outcomes
Overall Survival
Time frame: 1 year
Overall Survival
Time frame: 3 years
Prostate Specific Antigen response
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer Metastatic Disease
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RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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RecruitingPhase 1/2
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RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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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.
Andrea De Censi study chair
Ente Ospedaliero Ospedali Galliera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer Metastatic Disease, run by Monica Boitano at 1 site in Italy.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica Boitano (00390105634505, monica.boitano@galliera.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 1 year). The study lists 2 primary outcomes in all. 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 16 Jul 2025.