Prostatic AdenocarcinomaPhase 2NCT06015321
An Open Label Phase II Study of First-Line Maintenance Enzalutamide Following Docetaxel Plus Androgen-Deprivation Therapy in Patients With Previously-Untreated, Metastatic, Castration-Naive Prostatic Adenocarcinoma
A Phase 2 study testing Enzalutamide in people with Prostatic Adenocarcinoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Although surgical or medical castration (i.e., androgen-deprivation therapy, ADT) is considered standard treatment in metastatic castration-naïve PC (mCNPC) patients, current guidelines have established the addition docetaxel or modern androgen receptor targeting agents (ARTAs; abiraterone acetate or enzalutamide) to… Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Prostatic Adenocarcinoma
- What is being tested?
- Enzalutamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2023to 30 Apr 2026
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For inclusion of a subject in the study, all of the following inclusion criteria must be fulfilled:
- 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.
Show all 12Show fewer
- 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.
- Acceptable liver function:
- Acceptable renal function
- Acceptable hematologic status (without growth factor support or transfusion dependency):
- 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
- For inclusion of a subject in the study, any of the following inclusion criteria must not be fulfilled:
- 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.
- 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.
- Non-tolerable >Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1.
Show all 11Show fewer
- Major surgery, other than diagnostic surgery, within 4 weeks prior to Cycle 1 Day 1, without complete recovery.
- 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.
South Korea1 site
Samsung Medical Center
Seoul, Korea, 06531
Mijin Lee, 82-2-2008-4436
Sung Hee Lim, MD, Ph.D.
About this study
Official title: Open Label Trial of Maintenance Enzalutamide in CRPC
Although surgical or medical castration (i.e., androgen-deprivation therapy, ADT) is considered standard treatment in metastatic castration-naïve PC (mCNPC) patients, current guidelines have established the addition docetaxel or modern androgen receptor targeting agents (ARTAs; abiraterone acetate or enzalutamide) to ADT as the standard of care for patients with mCNPC [1,2]. One of the major challenges in the management of mCNPC includes balancing the toxicity of first-line docetaxel with clinical benefit. Our previous clinical studies suggested that the tolerability of docetaxel could be improved by using a biweekly regimen [3,4], without compromising efficacy. There is a growing interest in maintenance therapy as a strategy for prolonging the benefit of first-line therapy while minimizing long-term toxicity. In phase III trials involving first-line enzalutamide in mCNPC (ENZAMET and ARCHES), earlier treatment with docetaxel was permitted [5,6]. Based on these considerations, we hypothesized that enzalutamide maintenance therapy would improve outcomes in patients who had received first-line biweekly docetaxel plus ADT for mCNPC.
Read the detailed description
- Patients will receive docetaxel 40 mg/m2 IV every 2 weeks plus ADT. Docetaxel will be repeated on an outpatient basis and continued until disease progression, unacceptable toxicity, deterioration of clinical condition, patient refusal, or up to 6 to 8 cycles. ADT includes commercially available GNRH agonists such as goserelin, leuprolide and triptorelin, according to their market authorized approved label.
- After the receipt of 6 to 8 cycles of first-line docetaxel plus ADT, patients with no evidence of disease progression (i.e., biochemical and clinical) will receive enzalutamide 160 mg PO daily. Enzalutamide will be continued until disease progression (i.e., development of mCRPC), unacceptable toxicity, deterioration of clinical condition, patient refusal.
- Conditions
- Prostatic Adenocarcinoma
- Being tested
- Enzalutamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnzalutamideDrug
Also called XtandiTM
enzalutamide 160 mg PO daily
| Study group | Role | What they receive |
|---|---|---|
| Enzalutamide | Experimental | First-Line Maintenance Enzalutamide Following Docetaxel plus Androgen-Deprivation Therapy in Patients with Previously-Untreated, Metastatic, Castration-Naïve Prostatic Adenocarcinoma Receives: Drug: Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-CRPC (biochemical or clinical)
RECIST v1.1 criteria will be used to assess patient response to treatment
Measured: up tp 30months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Oct 2023 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic AdenocarcinomaStudies 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
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Hee Lim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015321
- Sponsor's protocol ID
- 2023-07-103
- Status last verified
- Aug 2023
- First submitted
- 23 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Trial of Maintenance Enzalutamide in CRPC
- ClinicalTrials.gov ID
- NCT06015321
- Acronym / sponsor ID
- 2023-07-103
- Conditions
- Prostatic Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 29 Aug 2023 (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.
Although surgical or medical castration (i.e., androgen-deprivation therapy, ADT) is considered standard treatment in metastatic castration-naïve PC (mCNPC) patients, current guidelines have established the addition docetaxel or modern androgen receptor targeting agents (ARTAs; abiraterone acetate or enzalutamide) to ADT as the standard of care for patients with mCNPC [1,2]. One of the major challenges in the management of mCNPC includes balancing the toxicity of first-line docetaxel with clinical benefit. Our previous clinical studies suggested that the tolerability of docetaxel could be improved by using a biweekly regimen [3,4], without compromising efficacy. There is a growing interest in maintenance therapy as a strategy for prolonging the benefit of first-line therapy while minimizing long-term toxicity. In phase III trials involving first-line enzalutamide in mCNPC (ENZAMET and ARCHES), earlier treatment with docetaxel was permitted [5,6]. Based on these considerations, we hypothesized that enzalutamide maintenance therapy would improve outcomes in patients who had received first-line biweekly docetaxel plus ADT for mCNPC.
Detailed description
- Patients will receive docetaxel 40 mg/m2 IV every 2 weeks plus ADT. Docetaxel will be repeated on an outpatient basis and continued until disease progression, unacceptable toxicity, deterioration of clinical condition, patient refusal, or up to 6 to 8 cycles. ADT includes commercially available GNRH agonists such as goserelin, leuprolide and triptorelin, according to their market authorized approved label.
- After the receipt of 6 to 8 cycles of first-line docetaxel plus ADT, patients with no evidence of disease progression (i.e., biochemical and clinical) will receive enzalutamide 160 mg PO daily. Enzalutamide will be continued until disease progression (i.e., development of mCRPC), unacceptable toxicity, deterioration of clinical condition, patient refusal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enzalutamide | Experimental | Drug: EnzalutamideFirst-Line Maintenance Enzalutamide Following Docetaxel plus Androgen-Deprivation Therapy in Patients with Previously-Untreated, Metastatic, Castration-Naïve Prostatic Adenocarcinoma |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- For inclusion of a subject in the study, all of the following inclusion criteria must be fulfilled:
Key exclusion criteria (11 listed)
- For inclusion of a subject in the study, any of the following inclusion criteria must not be fulfilled:
- 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.
- 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 |
|---|---|---|
| EnzalutamideAlso: XtandiTMenzalutamide 160 mg PO daily | Drug | Enzalutamide |
Primary outcome
Time-to-CRPC (biochemical or clinical)
Time frame: up tp 30months
RECIST v1.1 criteria will be used to assess patient response to treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Individual participant dataSharing planned: Yes
Related trials for Prostatic Adenocarcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 1
Hypofractionated Accelerated Pelvic Nodal Radiotherapy (GCC 2048)
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingObservational study
ProsBiT: Turkish Prostate Biopsy Study
Prostate Cancer (Adenocarcinoma), Prostatic Neoplams
RecruitingPhase 2
Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance
Adenocarcinoma, Prostate Cancer
RecruitingPhase 2
Study of Oral MRT-2359 With Apalutamide in Prostate Cancer
Castration-Resistant Prostate Cancer (CRPC), Castration-Resistant Prostate Cancer
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.
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 Enzalutamide in people with Prostatic Adenocarcinoma, 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 12 inclusion and 11 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 29 Aug 2023. 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?
Contact Sung Hee Lim, MD,Ph.D. (10-2018-9305 ext. 82, sunghee1022.lim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-CRPC (biochemical or clinical) (time frame: up tp 30months). 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 29 Aug 2023.