Prostate CancerECHOSNCT06473259
Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Agent (Alone or Combined) or Radiotherapy on Primary Tumor in Addition to Androgen Deprivation Therapy in HOrmone-Sensitive Metastatic Prostate Cancer Patients
An observational study of Prostate Cancer and Hormone Sensitive Prostate Cancer, run by Santa Chiara Hospital at 3 sites in Italy.
Trial summary
The aim of this observational study is to evaluate the clinical outcomes of treatment with docetaxel, ARTA (alone or in combination) or with radiotherapy on the primary tumor for mCSPC, in an unselected population, in clinical practice Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Hormone Sensitive Prostate Cancer, Metastatic Tumor
- What is being tested?
- Docetaxel, Apalutamide Oral Tablet and Enzalutamide Oral Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 3,000 participants
- Where
- 3 sitesItaly
- Study dates
- 16 Dec 2016to Dec 2028
- How long will I take part?
- 5 Years
- 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 Any age
- Men only
- Child, Adult, Older adult
Study population: All patients with mCSPC who initiated treatment with docetaxel, ARPI (alone or in combination) or with radiotherapy on the primary tumor in addition to ADT within clinical practice or expanded access programs in Italian hospitals from January 2015 to December 2027 will be studied.
Who may be able to join
- histologically confirmed diagnosis of adenocarcinoma of the prostate, metastatic, not undergoing previous treatment (except hormone therapy initiated no more than 4-6 months prior to docetaxel) for metastatic disease
- treatment with docetaxel, ARPI (alone or in combination) or with radiation therapy on the primary tumor in combination with ADT within normal clinical practice or expanded access programs initiated between January 2015 and December 2027.
- availability of inpatient and/or outpatient medical records for clinical data collection
Who cannot join
- histological diagnosis other than adenocarcinoma
- patients who have received multiple lines of ADT for mCSPC
- patients who have received docetaxel or ARTA for metastatic castration-resistant disease
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Recruiting
Azienda Ospedaliera San Luigi
Orbassano, Torino, 10043
Consuelo Buttigliero, MD, PhD, +390116705492, consuelo.buttigliero@unito.it
Consuelo Buttigliero, MD, PhD
- Recruiting
Istituto Oncologico Veneto
Padova, 35128
Umberto Basso, MD, +39-049-8215953, umberto.basso@iov.veneto.it
Basso Umberto
- Recruiting
Santa Chiara Hospital
Trento, 38122
Orazio Caffo, MD, +39 046190212, orazio.caffo@apss.tn.it
Orazio Caffo
About this study
Official title: Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Therapy (Alone or in Combination) or Radiotherapy on the Primary Tumor in Combination With Androgen Deprivation Therapy in Metastatic Hormone-sensitive Prostate Cancer: Multicenter Observational Study of Patients Undergoing Treatment in Clinical Practice in Italian Hospitals
The aim of this observational study is to evaluate the clinical outcomes of treatment with docetaxel, ARTA (alone or in combination) or with radiotherapy on the primary tumor for mCSPC, in an unselected population, in clinical practice
- Being tested
- Docetaxel, Apalutamide Oral Tablet, Enzalutamide Oral Tablet, Abiraterone acetate tablets, Darolutamide Oral Tablet
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
6 courses of docetaxel 75 mg/sqm iv
Apalutamide Oral TabletDrug
240 mg /daily orally
Enzalutamide Oral TabletDrug
600 mg /daily orally
Abiraterone acetate tabletsDrug
1000 mg /daily orally
Darolutamide Oral TabletDrug
600 mg/daily orally
radiotherapyRadiation
radical radiotherapy on primary tumor
TriptorelinDrug
3,75 mg im/4 w
| Study group | Role | What they receive |
|---|---|---|
| ADT + docetaxel | mHSPC patients treated with ADT + docetaxel Receives: Drug: Docetaxel; Drug: Triptorelin | |
| ADT + ARPI | mHSPC patients treated with ADT + ARPI Receives: Drug: Apalutamide Oral Tablet; Drug: Enzalutamide Oral Tablet; Drug: Abiraterone acetate tablets; Drug: Triptorelin | |
| ADT + ARPI + docetaxel | mHSPC patients treated with ADT + docetaxel + ARPI Receives: Drug: Docetaxel; Drug: Darolutamide Oral Tablet; Drug: Triptorelin | |
| ADT + radiotherapy on primary tumor | mHSPC patients treated with ADT + radiotherapy on primary tumor Receives: Radiation: radiotherapy; Drug: Triptorelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
the projected rate over the time of patients without progressive disease
Measured: From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Secondary outcomes (1)
overall survival
the projected rate over the time of alive patients
Measured: From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start16 Dec 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Santa Chiara Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orazio Caffo, Santa Chiara Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473259
- Sponsor's protocol ID
- A349
- Acronym
- ECHOS
- Status last verified
- Jun 2024
- First submitted
- 28 May 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Therapy (Alone or in Combination) or Radiotherapy on the Primary Tumor in Combination With Androgen Deprivation Therapy in Metastatic Hormone-sensitive Prostate Cancer: Multicenter Observational Study of Patients Undergoing Treatment in Clinical Practice in Italian Hospitals
- ClinicalTrials.gov ID
- NCT06473259
- Acronym / sponsor ID
- ECHOS / A349
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Santa Chiara HospitalUniversity, hospital or other
- Study start
- 16 Dec 2016 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 Jun 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.
The aim of this observational study is to evaluate the clinical outcomes of treatment with docetaxel, ARTA (alone or in combination) or with radiotherapy on the primary tumor for mCSPC, in an unselected population, in clinical practice
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ADT + docetaxel | – | Drug: Docetaxel, Drug: TriptorelinmHSPC patients treated with ADT + docetaxel |
| ADT + ARPI | – | Drug: Apalutamide Oral Tablet, Drug: Enzalutamide Oral Tablet, Drug: Abiraterone acetate tablets, Drug: TriptorelinmHSPC patients treated with ADT + ARPI |
| ADT + ARPI + docetaxel | – | Drug: Docetaxel, Drug: Darolutamide Oral Tablet, Drug: TriptorelinmHSPC patients treated with ADT + docetaxel + ARPI |
| ADT + radiotherapy on primary tumor | – | Radiation: radiotherapy, Drug: TriptorelinmHSPC patients treated with ADT + radiotherapy on primary tumor |
Who may qualify
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with mCSPC who initiated treatment with docetaxel, ARPI (alone or in combination) or with radiotherapy on the primary tumor in addition to ADT within clinical practice or expanded access programs in Italian hospitals from January 2015 to December 2027 will be studied.
Key inclusion criteria (3 listed)
- histologically confirmed diagnosis of adenocarcinoma of the prostate, metastatic, not undergoing previous treatment (except hormone therapy initiated no more than 4-6 months prior to docetaxel) for metastatic disease
- treatment with docetaxel, ARPI (alone or in combination) or with radiation therapy on the primary tumor in combination with ADT within normal clinical practice or expanded access programs initiated between January 2015 and December 2027.
- availability of inpatient and/or outpatient medical records for clinical data collection
Key exclusion criteria (3 listed)
- histological diagnosis other than adenocarcinoma
- patients who have received multiple lines of ADT for mCSPC
- patients who have received docetaxel or ARTA for metastatic castration-resistant 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 |
|---|---|---|
| Docetaxel6 courses of docetaxel 75 mg/sqm iv | Drug | ADT + ARPI + docetaxel, ADT + docetaxel |
| Apalutamide Oral Tablet240 mg /daily orally | Drug | ADT + ARPI |
| Enzalutamide Oral Tablet600 mg /daily orally | Drug | ADT + ARPI |
| Abiraterone acetate tablets1000 mg /daily orally | Drug | ADT + ARPI |
| Darolutamide Oral Tablet600 mg/daily orally | Drug | ADT + ARPI + docetaxel |
| radiotherapyradical radiotherapy on primary tumor | Radiation | ADT + radiotherapy on primary tumor |
| Triptorelin3,75 mg im/4 w | Drug | ADT + ARPI, ADT + ARPI + docetaxel, ADT + docetaxel, ADT + radiotherapy on primary tumor |
Primary outcome
progression free survival
Time frame: From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
the projected rate over the time of patients without progressive disease
1 secondary outcome
overall survival
Time frame: From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 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 25 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
3 sites 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 and Hormone Sensitive Prostate Cancer, run by Santa Chiara Hospital at 3 sites 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 3 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: looking for participants now, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Orazio Caffo, MD (+390461904416, orazio.caffo@apss.tn.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: From date of treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months). 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 25 Jun 2024.