Prostatic NeoplasmPhase 2NCT03061643
An Open Label Phase II Study of Biweekly Docetaxel Plus Androgen-Deprivation Therapy in Patients With Previously-Untreated, Metastatic, Prostatic Adenocarcinoma
A Phase 2 study testing Docetaxel and Androgen-Deprivation Therapy (ADT) in people with Prostatic Neoplasm, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Study of Biweekly Docetaxel plus Androgen-Deprivation Therapy (ADT) in Patients with Previously-Untreated, Metastatic, Prostatic Adenocarcinoma Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Prostatic Neoplasm
- What is being tested?
- Docetaxel and Androgen-Deprivation Therapy (ADT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Feb 2017to Jun 2022
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is a male at least 20 years of age.
- Subject has a histologically or cytologically confirmed diagnosis of adenocarcinoma of prostate.
- Subject has radiologic and clinical evidence of metastatic disease initially or after treatment for localized disease. They must have metastatic or progressive disease for which there is no further curative treatment available.
- Subject has an ECOG performance status of 0 to 1.
- Subject has a life expectancy of 3 months or more.
- At least 4 weeks since the last surgical procedures or radiotherapy prior to enrolment. Subjects must have recovered to <Grade 2 from all acute toxicities or toxicity must be deemed irreversible by the investigator.
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- Acceptable hematologic status (without growth factor support or transfusion dependency):
- Acceptable renal function with serum creatinine
- Acceptable liver function:
- Subject must agree to use an adequate method of contraception (condom) if he is having sex with a woman of childbearing potential or with a woman who is pregnant.
- Written and voluntary informed consent understood, signed and dated.
Who cannot join
- Ongoing treatment with an anticancer agent not contemplated in this protocol
- Pathologic finding consistent with neuroendocrine or small cell carcinoma
- Any history of clinically relevant coronary artery disease or myocardial infarction within the last 3 years, New York Heart Association (NYHA) grade III or greater congestive heart failure, cerebrovascular attack within the prior year, or current serious cardiac arrhythmia requiring medication except atrial fibrillation.
- Non-tolerable >Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1
- Known uncontrolled brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 4 weeks prior to Cycle 1 Day 1). Subjects that develop brain metastasis during the study may have their treatment interrupted to receive a course of cranial radiation and restart trial medication after a recovery period of at least 1 week. High dose corticosteroids may be employed for the management of cranial radiation but must be tapered off before resuming treatment.
- Major surgery, other than diagnostic surgery, within 4 weeks prior to Cycle 1 Day 1, without complete recovery.
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- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
- Subjects who have exhibited allergic reactions to taxanes.
- Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.
- The subject has legal incapacity or limited legal capacity. Dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with the requirements of this protocol. Unwillingness or inability to comply with the study protocol for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SAMSUNG MEDICAL CENTER
Study of Biweekly Docetaxel plus Androgen-Deprivation Therapy (ADT) in Patients with Previously-Untreated, Metastatic, Prostatic Adenocarcinoma
Read the detailed description
Although surgical or medical castration is considered standard treatment in hormone-naïve PC patients, some patients with extensive metastatic disease, including visceral or bone involvement beyond axial skeleton, have shorter survival. Based on the recent randomized trials (CHAARTED, GETUG-AFU15 and STAMPEDE), hormone-naïve men with metastatic, high-volume PC should be offered docetaxel plus ADT. However, side effects from standard 3-weekly 75 mg/m2 docetaxel can be substantial. In addition, a prospective trial is needed to determine whether early docetaxel chemotherapy in combination with ADT is beneficial in Korean men. Considering our own experiences with docetaxel, a dose intensity of 20 mg/m2/week (equivalent to 60 mg/m2 3-weekly or 40 mg/m2 biweekly) should be tested in the prospective trial.
- Conditions
- Prostatic Neoplasm
- Being tested
- Docetaxel, Androgen-Deprivation Therapy (ADT)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
docetaxel 40 mg/m2 IV every 2 weeks plus ADT
Androgen-Deprivation Therapy (ADT)Other
docetaxel 40 mg/m2 IV every 2 weeks plus ADT
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel PLUS ADT | Experimental | receive docetaxel 40 mg/m2 IV every 2 weeks plus ADT Receives: Drug: Docetaxel; Other: Androgen-Deprivation Therapy (ADT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-CRPC (biochemical or clinical)
Measured: 24 months
Secondary outcomes (1)
Progression-free survival
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start8 Feb 2017
- Primary completionMar 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Park, Se-Hoon, Samsung Medical Center
- Investigators
- SEHOON SEHOON, MD,PhD, Principal investigator, SamsungMedicalCenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061643
- Sponsor's protocol ID
- 2017-01-005
- Status last verified
- Mar 2022
- First submitted
- 20 Feb 2017
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAMSUNG MEDICAL CENTER
- ClinicalTrials.gov ID
- NCT03061643
- Acronym / sponsor ID
- 2017-01-005
- Conditions
- Prostatic Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 23 Feb 2017 (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.
Study of Biweekly Docetaxel plus Androgen-Deprivation Therapy (ADT) in Patients with Previously-Untreated, Metastatic, Prostatic Adenocarcinoma
Detailed description
Although surgical or medical castration is considered standard treatment in hormone-naïve PC patients, some patients with extensive metastatic disease, including visceral or bone involvement beyond axial skeleton, have shorter survival. Based on the recent randomized trials (CHAARTED, GETUG-AFU15 and STAMPEDE), hormone-naïve men with metastatic, high-volume PC should be offered docetaxel plus ADT. However, side effects from standard 3-weekly 75 mg/m2 docetaxel can be substantial. In addition, a prospective trial is needed to determine whether early docetaxel chemotherapy in combination with ADT is beneficial in Korean men. Considering our own experiences with docetaxel, a dose intensity of 20 mg/m2/week (equivalent to 60 mg/m2 3-weekly or 40 mg/m2 biweekly) should be tested in the prospective trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel PLUS ADT | Experimental | Drug: Docetaxel, Other: Androgen-Deprivation Therapy (ADT)receive docetaxel 40 mg/m2 IV every 2 weeks plus ADT |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is a male at least 20 years of age.
- Subject has a histologically or cytologically confirmed diagnosis of adenocarcinoma of prostate.
- Subject has radiologic and clinical evidence of metastatic disease initially or after treatment for localized disease. They must have metastatic or progressive disease for which there is no further curative treatment available.
- Subject has an ECOG performance status of 0 to 1.
- Subject has a life expectancy of 3 months or more.
Key exclusion criteria (10 listed)
- Ongoing treatment with an anticancer agent not contemplated in this protocol
- Pathologic finding consistent with neuroendocrine or small cell carcinoma
- Any history of clinically relevant coronary artery disease or myocardial infarction within the last 3 years, New York Heart Association (NYHA) grade III or greater congestive heart failure, cerebrovascular attack within the prior year, or current serious cardiac arrhythmia requiring medication except atrial fibrillation.
- Non-tolerable >Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1
- Known uncontrolled brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 4 weeks prior to Cycle 1 Day 1). Subjects that develop brain metastasis during the study may have their treatment interrupted to receive a course of cranial radiation and restart trial medication after a recovery period of at least 1 week. High dose corticosteroids may be employed for the management of cranial radiation but must be tapered off before resuming treatment.
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 |
|---|---|---|
| Docetaxeldocetaxel 40 mg/m2 IV every 2 weeks plus ADT | Drug | Docetaxel PLUS ADT |
| Androgen-Deprivation Therapy (ADT)docetaxel 40 mg/m2 IV every 2 weeks plus ADT | Other | Docetaxel PLUS ADT |
Primary outcome
Time-to-CRPC (biochemical or clinical)
Time frame: 24 months
1 secondary outcome
Progression-free survival
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
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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.
SEHOON SEHOON, MD,PhD principal investigator
SamsungMedicalCenter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel and Androgen-Deprivation Therapy (ADT) in people with Prostatic Neoplasm, run by Samsung Medical Center at 1 site in South Korea.
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: status not confirmed, as of the sponsor's last update on 8 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 1 site in South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Time-to-CRPC (biochemical or clinical) (time frame: 24 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 8 Mar 2022.