Prostate CancerPhase 4NCT02918968
Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer
A Phase 4 study testing Enzalutamide, Flutamide and Androgen deprivation therapy in people with Prostate Cancer, run by Astellas Pharma Inc at 47 sites in Japan.
Trial summary
The objective of this study was to compare the efficacy and safety of the combination therapy with enzalutamide + androgen deprivation therapy (ADT) and the combination therapy with flutamide + ADT in patients with castration resistant prostate cancer who had relapsed during combined androgen blockade (CAB) therapy… Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Enzalutamide, Flutamide and Androgen deprivation therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 47 sitesJapan
- Study dates
- 2 Nov 2016to 27 Mar 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small-cell histology.
- Subject on continuous ADT with Gonadotropin Releasing Hormone (GnRH) agonist/antagonist or bilateral orchiectomy.
- Serum testosterone level below the target level at screening visit.
- Subject with asymptomatic or mildly symptomatic prostate cancer.
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subject has progression of the disease as defined by rising PSA levels or progressive soft tissue or bony disease during CAB therapy in combination of bicalutamide and ADT.
- A sexually active male subject and the subject's female partner who is of childbearing potential must use 2 acceptable birth control methods from screening to 3 months after the last dose of the study drug.
- Subject must agree not to donate sperm from screening to 3 months after the last dose of the study drug.
Who cannot join
- Subject with severe concurrent diseases, infections, or complications.
- Subject with confirmed or suspected brain metastasis or active leptomeningeal metastasis.
- Subject with a history of malignant tumor other than prostate cancer in the past 5 years.
- Subject hypersensitive to the ingredients of enzalutamide capsules or flutamide tablets.
- Subject with a history of convulsive attack, or prone to convulsive attack.
- Subject with liver disorder such as viral hepatitis and hepatic cirrhosis, or subject with Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) at screening visit higher than the upper limit of normal.
- Subject received treatment for prostate cancer with cytocidal chemotherapy that includes anti androgenic agents other than bicalutamide, abiraterone, or estramustine.
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
Japan47 sites
Site JP00011
Bunkyo-ku, Tokyo
Site JP00017
Bunkyo-ku, Tokyo
Site JP00010
Chiba
Site JP00053
Chiba
Site JP00039
Fukuoka
Site JP00040
Fukuoka
Site JP00050
Fukuoka
Site JP00054
Hakodate, Hokkaido
Site JP00022
Hamamatsu, Shizuoka
Site JP00028
Hirakata, Osaka
Site JP00035
Hiroshima
Site JP00051
Iizuka, Fukuoka
Site JP00045
Isesaki, Gunma
Site JP00046
Kashihara, Nara
Site JP00009
Kitaadachi-gun, Saitama
Site JP00013
Koto-ku, Tokyo
Site JP00033
Kurashiki, Okayama-ken
Site JP00026
Kyoto
Site JP00005
Maebashi, Gunma
Site JP00038
Matsuyama, Ehime
Site JP00055
Mito, Ibaraki
Site JP00006
Nagano
Site JP00008
Nagano
Site JP00041
Nagasaki
Site JP00024
Nagoya, Aichi-ken
Site JP00025
Nagoya, Aichi-ken
Site JP00014
Nakano-ku, Tokyo
Site JP00029
Osaka
Site JP00031
Osaka
Site JP00032
Osaka
Site JP00043
Ōta, Gunma
Site JP00042
Saga
Site JP00019
Sagamihara, Kanagawa
Site JP00001
Sapporo, Hokkaido
Site JP00002
Sapporo, Hokkaido
Site JP00048
Sapporo, Hokkaido
Site JP00030
Sayama, Osaka
Site JP00016
Shinagawa-ku, Tokyo
Site JP00018
Shinjuku-ku, Tokyo
Site JP00027
Suita, Osaka
Site JP00037
Tokushima
Site JP00052
Toyama
Site JP00034
Ube, Yamaguchi
Site JP00049
Utsunomiya, Tochigi
Site JP00020
Yokohama, Kanagawa
Site JP00021
Yokohama, Kanagawa
Site JP00044
Yokosuka, Kanagawa
About this study
Official title: A Randomized Phase IV Study Comparing Enzalutamide Versus Flutamide in Castration-resistant Prostate Cancer (CRPC) Patients Who Have Failed Combined Androgen Blockade Therapy With Bicalutamide Plus Androgen Deprivation Therapy (ADT)
The objective of this study was to compare the efficacy and safety of the combination therapy with enzalutamide + androgen deprivation therapy (ADT) and the combination therapy with flutamide + ADT in patients with castration resistant prostate cancer who had relapsed during combined androgen blockade (CAB) therapy with bicalutamide and ADT. This study also investigated the order of alternative antiandrogen therapy (AAT) by changing the 1st line medication after relapse of prostate-specific antigen (PSA).
- Conditions
- Prostate Cancer
- Being tested
- Enzalutamide, Flutamide, Androgen deprivation therapy
- Keywords
- enzalutamide, Xtandi, 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.
EnzalutamideDrug
Also called Xtandi, MDV3100
Oral Capsule
FlutamideDrug
Oral tablet
Androgen deprivation therapyOther
All subjects must undergo continuous Androgen deprivation therapy with GnRH agonist/antagonist or bilateral orchiectomy during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Enzalutamide 160 mg 1st line AAT/Flutamide 375 mg 2nd line AAT | Experimental | Participants received enzalutamide 160 mg capsules, orally once daily as 1st line of alternative antiandrogen therapy (AAT) until confirmed prostate-specific antigen (PSA) progression, other disease progression, or an intolerable adverse event. After confirmation of PSA progression, other disease progression, or an intolerable adverse event, participants received flutamide 125 mg tablets orally thrice daily after each meal as 2nd line of AAT. Treatment with each drug was continued until the participant met any of the discontinuation criteria or until 2 years from the enrollment of the last participant (approximately 38 months). Receives: Drug: Enzalutamide; Drug: Flutamide; Other: Androgen deprivation therapy |
| Flutamide 375 mg 1st line AAT/Enzaltumide 160 mg 2nd line AAT | Experimental | Participants received flutamide 125 mg tablets orally thrice daily after each meal as 1st line of AAT until confirmed PSA progression, other disease progression, or an intolerable adverse event. After confirmed PSA progression, other disease progression, or an intolerable adverse event. participants received enzalutamide 160 mg capsules orally once daily as 2nd line of AAT. Treatment with each drug was continued until the participant met any of the discontinuation criteria or until 2 years from the enrollment of the last participant (approximately 38 months). Receives: Drug: Enzalutamide; Drug: Flutamide; Other: Androgen deprivation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to PSA Progression With 1st Line AAT (TTPP1)
TTPP1 was defined as the period from the date of randomization to the date of PSA progression in the 1st line AAT period. PSA progression was defined according to the consensus guidelines of prostate cancer clinical trials working group 2 (PCWG2). For participants with PSA declines at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir were documented, which was confirmed by a second consecutive value obtained 3 or more weeks later. For participants with no PSA decline at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline were documented. Time to event analysis was performed using kaplan-meier (KM) estimates.
Measured: From date of randomization to the date of PSA progression in the 1st line AAT period (Up to 38 months)
Secondary outcomes (7)
Time to PSA Progression With 2nd Line AAT (TTPP2)
TTPP2 was defined as the period from day 1 of the 2nd line AAT to the date of PSA progression with the 2nd line AAT. PSA progression was defined according to the consensus guidelines of PCWG2. For participants with PSA declines at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir were documented, which was confirmed by a second consecutive value obtained 3 or more weeks later. For participants with no PSA decline at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline were documented. Time to event analysis was performed using kaplan-meier estimates.
Measured: From date of randomization to the date of PSA progression in 2nd line AAT (Up to 38 months)
Percentage of Participants Achieving at Least 50 or 90 Percent (%) Reduction From Baseline and Up To Week 38 in Prostate Specific Antigen (PSA) Response at 1st Line AAT
PSA response was defined as PSA decreased by at least 50% or 90% from baseline when at least 3 weeks passed after the lowest PSA decreased by at least 50% or 90% from baseline in the 1st line AAT period after baseline.
Data was reported per each disease stage (M0/N0, M0/N1, M1). 1) M0/N0: No distant metastasis and no lymph node metastasis. 2) M0/N1: Without distant metastasis, but with metastasis in lymph nodes distal to the aortic bifurcation. 3) M1: With distant metastasis (including metastasis in lymph nodes proximal to the aortic bifurcation).
Measured: Baseline and at least 3 weeks after, the lowest PSA decreased by at least 50% or 90% from baseline (Up to 38 months)
Percentage of Participants Achieving at Least 50 or 90 Percent (%) Reduction From Baseline to Week 13 in Prostate Specific Antigen (PSA) Response at 1st Line AAT
PSA response was defined as the lowest PSA at week 13 decreased by at least 50% or 90% from baseline in the 1st line AAT period.
Data was reported per each disease stage (M0/N0, M0/N1, M1). 1) M0/N0: No distant metastasis and no lymph node metastasis. 2) M0/N1: Without distant metastasis, but with metastasis in lymph nodes distal to the aortic bifurcation. 3) M1: With distant metastasis (including metastasis in lymph nodes proximal to the aortic bifurcation).
Measured: Baseline and week 13
Time to PSA Decrease by 50% From Baseline With 1st Line AAT
Time to PSA decrease by 50% with 1st line AAT was defined as the period from the date of randomization to the day when the decrease of PSA from baseline by 50% is first identified. Time to event analysis was performed using kaplan-meier estimates.
Data was reported per each disease stage (M0/N0, M0/N1, M1). 1) M0/N0: No distant metastasis and no lymph node metastasis. 2) M0/N1: Without distant metastasis, but with metastasis in lymph nodes distal to the aortic bifurcation. 3) M1: With distant metastasis (including metastasis in lymph nodes proximal to the aortic bifurcation).
Measured: From date of randomization to the day when the decrease of PSA from baseline by 50% is first identified (Up to 38 months)
Time to Treatment Failure of 1st Line AAT (TTF1)
TTF1 was defined as the period from randomization to study drug discontinuation of 1st line AAT for any reason that includes disease progression, onset of adverse events (AEs), participants request, or death. Time to event analysis was performed using kaplan-meier estimates.
Data was reported per each disease stage (M0/N0, M0/N1, M1). 1) M0/N0: No distant metastasis and no lymph node metastasis. 2) M0/N1: Without distant metastasis, but with metastasis in lymph nodes distal to the aortic bifurcation. 3) M1: With distant metastasis (including metastasis in lymph nodes proximal to the aortic bifurcation).
Measured: From date of randomization to discontinuation of 1st line AAT (Up to 38 months)
Time to Treatment Failure of 2nd Line AAT (TTF2)
TTF2 was defined as the period from randomization to study drug discontinuation of 2nd line AAT for any reason that includes disease progression, onset of AEs, participants request, or death. Time to event analysis was performed using kaplan-meier estimates.
Measured: From date of randomization to discontinuation of 2nd line AAT (Up to 38 months)
Radiographic Progression-free Survival (rPFS)
rPFS was defined as the period from randomization to the time when radiographic disease progression is observed or death of any cause during the study period, whichever occurs earlier. Time to event analysis was performed using kaplan-meier estimates.
Data was reported per each disease stage (M0/N0, M0/N1, M1). 1) M0/N0: No distant metastasis and no lymph node metastasis. 2) M0/N1: Without distant metastasis, but with metastasis in lymph nodes distal to the aortic bifurcation. 3) M1: With distant metastasis (including metastasis in lymph nodes proximal to the aortic bifurcation).
Measured: From date of randomization to the time when radiographic disease progression is observed or death of any cause (up to 38 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study start2 Nov 2016
- Primary completion27 Mar 2020
- Study completion27 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918968
- Sponsor's protocol ID
- 9785-MA-3051
- Status last verified
- Nov 2024
- First submitted
- 27 Sep 2016
- Last updated
- 9 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase IV Study Comparing Enzalutamide Versus Flutamide in Castration-resistant Prostate Cancer (CRPC) Patients Who Have Failed Combined Androgen Blockade Therapy With Bicalutamide Plus Androgen Deprivation Therapy (ADT)
- ClinicalTrials.gov ID
- NCT02918968
- Acronym / sponsor ID
- 9785-MA-3051
- Conditions
- Prostate Cancer
- Keywords
- enzalutamide, Xtandi, Prostate Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 2 Nov 2016 (actual)
- Primary completion
- 27 Mar 2020 (actual)
- Study completion
- 27 Mar 2020 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Posted 21 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to compare the efficacy and safety of the combination therapy with enzalutamide + androgen deprivation therapy (ADT) and the combination therapy with flutamide + ADT in patients with castration resistant prostate cancer who had relapsed during combined androgen blockade (CAB) therapy with bicalutamide and ADT. This study also investigated the order of alternative antiandrogen therapy (AAT) by changing the 1st line medication after relapse of prostate-specific antigen (PSA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enzalutamide 160 mg 1st line AAT/Flutamide 375 mg 2nd line AAT | Experimental | Drug: Enzalutamide, Drug: Flutamide, Other: Androgen deprivation therapyParticipants received enzalutamide 160 mg capsules, orally once daily as 1st line of alternative antiandrogen therapy (AAT) until confirmed prostate-specific antigen (PSA) progression, other disease progression, or an intolerable adverse event. After confirmation of PSA progression, other disease progression, or an intolerable adverse event, participants received flutamide 125 mg tablets orally thrice daily after each meal as 2nd line of AAT. Treatment with each drug was continued until the participant met any of the discontinuation criteria or until 2 years from the enrollment of the last participant (approximately 38 months). |
| Flutamide 375 mg 1st line AAT/Enzaltumide 160 mg 2nd line AAT | Experimental | Drug: Enzalutamide, Drug: Flutamide, Other: Androgen deprivation therapyParticipants received flutamide 125 mg tablets orally thrice daily after each meal as 1st line of AAT until confirmed PSA progression, other disease progression, or an intolerable adverse event. After confirmed PSA progression, other disease progression, or an intolerable adverse event. participants received enzalutamide 160 mg capsules orally once daily as 2nd line of AAT. Treatment with each drug was continued until the participant met any of the discontinuation criteria or until 2 years from the enrollment of the last participant (approximately 38 months). |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small-cell histology.
- Subject on continuous ADT with Gonadotropin Releasing Hormone (GnRH) agonist/antagonist or bilateral orchiectomy.
- Serum testosterone level below the target level at screening visit.
- Subject with asymptomatic or mildly symptomatic prostate cancer.
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (7 listed)
- Subject with severe concurrent diseases, infections, or complications.
- Subject with confirmed or suspected brain metastasis or active leptomeningeal metastasis.
- Subject with a history of malignant tumor other than prostate cancer in the past 5 years.
- Subject hypersensitive to the ingredients of enzalutamide capsules or flutamide tablets.
- Subject with a history of convulsive attack, or prone to convulsive attack.
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: Xtandi, MDV3100Oral Capsule | Drug | Enzalutamide 160 mg 1st line AAT/Flutamide 375 mg 2nd line AAT, Flutamide 375 mg 1st line AAT/Enzaltumide 160 mg 2nd line AAT |
| FlutamideOral tablet | Drug | Enzalutamide 160 mg 1st line AAT/Flutamide 375 mg 2nd line AAT, Flutamide 375 mg 1st line AAT/Enzaltumide 160 mg 2nd line AAT |
| Androgen deprivation therapyAll subjects must undergo continuous Androgen deprivation therapy with GnRH agonist/antagonist or bilateral orchiectomy during the study period. | Other | Enzalutamide 160 mg 1st line AAT/Flutamide 375 mg 2nd line AAT, Flutamide 375 mg 1st line AAT/Enzaltumide 160 mg 2nd line AAT |
Primary outcome
Time to PSA Progression With 1st Line AAT (TTPP1)
Time frame: From date of randomization to the date of PSA progression in the 1st line AAT period (Up to 38 months)
TTPP1 was defined as the period from the date of randomization to the date of PSA progression in the 1st line AAT period. PSA progression was defined according to the consensus guidelines of prostate cancer clinical trials working group 2 (PCWG2). For participants with PSA declines at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir were documented, which was confirmed by a second consecutive value obtained 3 or more weeks later. For participants with no PSA decline at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline were documented. Time to event analysis was performed using kaplan-meier (KM) estimates.
7 secondary outcomes
Time to PSA Progression With 2nd Line AAT (TTPP2)
Time frame: From date of randomization to the date of PSA progression in 2nd line AAT (Up to 38 months)
Percentage of Participants Achieving at Least 50 or 90 Percent (%) Reduction From Baseline and Up To Week 38 in Prostate Specific Antigen (PSA) Response at 1st Line AAT
Time frame: Baseline and at least 3 weeks after, the lowest PSA decreased by at least 50% or 90% from baseline (Up to 38 months)
Percentage of Participants Achieving at Least 50 or 90 Percent (%) Reduction From Baseline to Week 13 in Prostate Specific Antigen (PSA) Response at 1st Line AAT
Time frame: Baseline and week 13
Time to PSA Decrease by 50% From Baseline With 1st Line AAT
Time frame: From date of randomization to the day when the decrease of PSA from baseline by 50% is first identified (Up to 38 months)
Time to Treatment Failure of 1st Line AAT (TTF1)
Time frame: From date of randomization to discontinuation of 1st line AAT (Up to 38 months)
Time to Treatment Failure of 2nd Line AAT (TTF2)
Time frame: From date of randomization to discontinuation of 2nd line AAT (Up to 38 months)
Radiographic Progression-free Survival (rPFS)
Time frame: From date of randomization to the time when radiographic disease progression is observed or death of any cause (up to 38 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Related trials for Prostate Cancer
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.
Medical Director study director
Astellas Pharma Inc
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enzalutamide, Flutamide and Androgen deprivation therapy in people with Prostate Cancer, run by Astellas Pharma Inc at 47 sites in Japan.
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 8 inclusion and 7 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: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Japan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 PSA Progression With 1st Line AAT (TTPP1) (time frame: From date of randomization to the date of PSA progression in the 1st line AAT period (Up to 38 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 9 Dec 2024.