Prostatic NeoplasmsPhase 3PROSTATANCT00705822
Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer
A Phase 3 study testing Docetaxel + Estramustine + Hydrocortisone and Docetaxel + Prednisone in people with Prostatic Neoplasms, run by Sanofi at 1 site in Spain.
Trial summary
To compare the efficacy of both strategies (reference treatment: Docetaxel+Prednisone and experimental treatment: Docetaxel+Estramustine+Hydrocortisone) by means of PSA values. To determine the time to treatment failure in both strategies To determine the overall and specific cause survival To evaluate the safety… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Docetaxel + Estramustine + Hydrocortisone and Docetaxel + Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2006to Jul 2009
- Phase
- Phase 3
- 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological confirmation of prostate adenocarcinoma
- Advanced prostate carcinoma.
- Previous treatment with hormones
- Levels of testosterone < 50 ng/dL
- Good hematological, liver and kidney function
- Previous treatment with surgery or radiotherapy, at least 4 weeks since end of treatment is allowed (the patient should have been recovered from any side effects.
Who cannot join
- Previous chemotherapy (estramustine included).
- Second line hormonotherapy (oestrogens, gestagens, ketoconazole, ...included)
- Previous treatment with radiotherapy (isotopes) or previous radiotherapy over > 25% of the marrow
- Any malignant process with a free disease interval under 5 years, exception done to non-melanoma skin cancer.
- Concomitant serious diseases
- Concomitant treatment with any other neoplassic therapy (exception done to LHRH agonists and/or biphosphonates).
Show all 10Show fewer
- Contraindication for the treatment with estramustine.
- Previous history of pulmonary embolism, thromboembolic disease, previous treatment with anticoagulants (except aspirin), active thrombophlebitis or hypercoagulation.
- Previous history of pulmonary spillage or ascitis.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer Who Have Relapse in Biochemistry Whilst Androgenic Blockage
To compare the efficacy of both strategies (reference treatment: Docetaxel+Prednisone and experimental treatment: Docetaxel+Estramustine+Hydrocortisone) by means of PSA values.
To determine the time to treatment failure in both strategies To determine the overall and specific cause survival To evaluate the safety profile To analyze the Quality of Life
- Conditions
- Prostatic Neoplasms
- Being tested
- Docetaxel + Estramustine + Hydrocortisone, Docetaxel + Prednisone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel + Estramustine + HydrocortisoneDrug
Docetaxel iv 80 mg + Oral estramustine-pills 140 mg + Oral hydrocortisone-pills 20 mg.
Combination of these 3 drugs every 3 weeks
Docetaxel + PrednisoneDrug
Docetaxel iv 80 mg + oral prednisone-pills 5 mg. Combination of these 2 drugs every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Docetaxel + Estramustine + Hydrocortisone Receives: Drug: Docetaxel + Estramustine + Hydrocortisone |
| 2 | Active comparator | Docetaxel + Prednisone Receives: Drug: Docetaxel + Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate over 50% in PSA
Measured: every 3 weeks up to end of treatment and every month until PSA progression
Secondary outcomes (5)
Time to treatment failure
Measured: from Informed Consent signature up to end of the study
Time to progression
Measured: from Informed Consent signature up to study end
Overall and specific cause surveillance
Measured: from Informed Consent signature up to study end
Toxicity profile
Measured: from Informed Consent signature up to study end
Patients' Quality of Life
Measured: Before first cycle, every 2 cycles throughout the treatment period, at the study end and first follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2008 (estimated)
- Study startAug 2006
- Primary completionJul 2009
- Study completionJul 2009
Why it stopped: low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- José Taboada, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705822
- Sponsor's protocol ID
- XRP6976J_3502
- Other IDs
- EudraCT #: 2004-003885-14
- Acronym
- PROSTATA
- Status last verified
- Nov 2010
- First submitted
- 24 Jun 2008
- Last updated
- 30 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer Who Have Relapse in Biochemistry Whilst Androgenic Blockage
- ClinicalTrials.gov ID
- NCT00705822
- Acronym / sponsor ID
- PROSTATA / XRP6976J_3502
- Conditions
- Prostatic Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment rate
- Enrolment
- 54 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 26 Jun 2008 (estimated)
- 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.
To compare the efficacy of both strategies (reference treatment: Docetaxel+Prednisone and experimental treatment: Docetaxel+Estramustine+Hydrocortisone) by means of PSA values.
To determine the time to treatment failure in both strategies To determine the overall and specific cause survival To evaluate the safety profile To analyze the Quality of Life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Docetaxel + Estramustine + HydrocortisoneDocetaxel + Estramustine + Hydrocortisone |
| 2 | Active comparator | Drug: Docetaxel + PrednisoneDocetaxel + Prednisone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histological or cytological confirmation of prostate adenocarcinoma
- Advanced prostate carcinoma.
- Previous treatment with hormones
- Levels of testosterone < 50 ng/dL
- Good hematological, liver and kidney function
Key exclusion criteria (10 listed)
- Previous chemotherapy (estramustine included).
- Second line hormonotherapy (oestrogens, gestagens, ketoconazole, ...included)
- Previous treatment with radiotherapy (isotopes) or previous radiotherapy over > 25% of the marrow
- Any malignant process with a free disease interval under 5 years, exception done to non-melanoma skin cancer.
- Concomitant serious diseases
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 |
|---|---|---|
| Docetaxel + Estramustine + HydrocortisoneDocetaxel iv 80 mg + Oral estramustine-pills 140 mg + Oral hydrocortisone-pills 20 mg. Combination of these 3 drugs every 3 weeks | Drug | 1 |
| Docetaxel + PrednisoneDocetaxel iv 80 mg + oral prednisone-pills 5 mg. Combination of these 2 drugs every 3 weeks. | Drug | 2 |
Primary outcome
Response rate over 50% in PSA
Time frame: every 3 weeks up to end of treatment and every month until PSA progression
5 secondary outcomes
Time to treatment failure
Time frame: from Informed Consent signature up to end of the study
Time to progression
Time frame: from Informed Consent signature up to study end
Overall and specific cause surveillance
Time frame: from Informed Consent signature up to study end
Toxicity profile
Time frame: from Informed Consent signature up to study end
Patients' Quality of Life
Time frame: Before first cycle, every 2 cycles throughout the treatment period, at the study end and first follow-up visit
Results and safety
The study was stopped early (reason given: low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2010.
Related trials for Prostatic Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
José Taboada study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel + Estramustine + Hydrocortisone and Docetaxel + Prednisone in people with Prostatic Neoplasms, run by Sanofi at 1 site in Spain.
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 6 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: stopped early, as of the sponsor's last update on 30 Nov 2010. 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 Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: low recruitment rate). Results are not available in the source record.
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?
Response rate over 50% in PSA (time frame: every 3 weeks up to end of treatment and every month until PSA progression). 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 30 Nov 2010.