Castration-resistant Prostate CancerPhase 2NCT02346578
Comparative Study of Alternative Antiandrogen (AA) Therapy and Early Initiating of Enzalutamide for Castration-resistant Prostate Cancer (CRPC) After Combined Androgen Blockade (CAB) Therapy.
A Phase 2 study testing Enzalutamide and Flutamide in people with Castration-resistant Prostate Cancer, run by Taro Iguchi, MD, PHD at 1 site in Japan.
Trial summary
The objective of this study is to compare the efficacy and safety of enzalutamide or alternative AA therapy in CRPC participants who were previously treated with a combined androgen blockade therapy which included bicalutamide (Bic-CAB). Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Castration-resistant Prostate Cancer
- What is being tested?
- Enzalutamide and Flutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2014to 22 Jan 2019
- 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
- Testosterone of less than 50 ng/dL
- Participants who was detected of disease progression on image or relapse of PSA (All PSA values measured 3 time at least one week interval are consecutively increased and final value is 2 ng/mL or more. If third value is not higher than second one, fourth measurement will be undertaken and its value must be higher than second one.)
- Participants who relapsed after CAB with bicalutamide
- Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1
- Aged 20 years or older
- Participants who provided written informed consent
Who cannot join
- Any prior treatment with enzalutamide, flutamide, abiraterone or chemotherapy, except for neoadjuvant therapy
- With active double cancer
- Any prior treatment with bicalutamide within 6 weeks
- Participants who received systemic biological therapy (except for existing approved drug for bone or treatment with luteinizing hormone-releasing hormone (LHRH) analogue) or received treatment with other antitumor agent for prostate cancer
- With serious complication
- History of hypersensitivity to enzalutamide or any other excipient of enzalutamide
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- History of hypersensitivity to flutamide-containing agent
- With liver dysfunction
- Participants who are considered as inadequate by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Prospective, Randomised and Comparative Study of AA Therapy and Early Administrating Enzalutamide in Participants With CRPC Previously Treated With CAB Therapy Using Bicalutamide.
The objective of this study is to compare the efficacy and safety of enzalutamide or alternative AA therapy in CRPC participants who were previously treated with a combined androgen blockade therapy which included bicalutamide (Bic-CAB). Efficacy and safety of enzalutamide and alternative AA therapy will be evaluated, and effective therapy against CRPC after treatment with Bic-CAB will be investigated.
- Conditions
- Castration-resistant Prostate Cancer
- Being tested
- Enzalutamide, Flutamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnzalutamideDrug
FlutamideDrug
| Study group | Role | What they receive |
|---|---|---|
| Enzalutamide | Experimental | Enzalutamide 160 mg administered orally once a day as four 40-mg soft capsules Receives: Drug: Enzalutamide |
| Flutamide | Active comparator | Flutamide 125 mg administered orally three times a day as one tablet after meal Receives: Drug: Flutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants whose prostate specific antigen (PSA) decreased 50 percent or more at month 3
Measured: Month 3
Secondary outcomes (5)
Percentage of participants whose PSA decreased 50 percent or more at month 6
Measured: Month 6
Percentage of participants who showed disease progression at month 3
Measured: Month 3
Percentage of participants who showed disease progression at month 6
Measured: Month 6
PSA progression-free survival (PFS)
Measured: Up to 39 months
QOL measured by functional assessment of cancer therapy-prostate (FACT-P)
Measured: Up to 39 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startDec 2014
- Primary completion30 Sep 2018
- Study completion22 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Castration-resistant 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taro Iguchi, MD, PHD
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor-investigator, Taro Iguchi, MD, PHD, Osaka City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346578
- Sponsor's protocol ID
- OCUU-CRPC
- Status last verified
- Sep 2021
- First submitted
- 15 Jan 2015
- Last updated
- 16 Sep 2021
- Results posted
- No
Publications
Iguchi T, Tamada S, Kato M, Yasuda S, Yamasaki T, Nakatani T. Enzalutamide versus flutamide for castration-resistant prostate cancer after combined androgen blockade therapy with bicalutamide: study protocol for a multicenter randomized phase II trial (the OCUU-CRPC study). BMC Cancer. 2019 Apr 11;19(1):339. doi: 10.1186/s12885-019-5526-3.
PubMed 30971225Iguchi T, Tamada S, Kato M, Yasuda S, Machida Y, Ohmachi T, Ishii K, Iwata H, Yamamoto S, Kanamaru T, Morimoto K, Hase T, Tashiro K, Harimoto K, Deguchi T, Adachi T, Iwamoto K, Takegaki Y, Nakatani T. Enzalutamide versus flutamide for castration-resistant prostate cancer after combined androgen blockade therapy with bicalutamide: the OCUU-CRPC study. Int J Clin Oncol. 2020 Mar;25(3):486-494. doi: 10.1007/s10147-019-01554-3. Epub 2019 Sep 28.
PubMed 31564004
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Randomised and Comparative Study of AA Therapy and Early Administrating Enzalutamide in Participants With CRPC Previously Treated With CAB Therapy Using Bicalutamide.
- ClinicalTrials.gov ID
- NCT02346578
- Acronym / sponsor ID
- OCUU-CRPC
- Conditions
- Castration-resistant Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Taro Iguchi, MD, PHDUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- Dec 2014
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 27 Jan 2015 (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.
The objective of this study is to compare the efficacy and safety of enzalutamide or alternative AA therapy in CRPC participants who were previously treated with a combined androgen blockade therapy which included bicalutamide (Bic-CAB). Efficacy and safety of enzalutamide and alternative AA therapy will be evaluated, and effective therapy against CRPC after treatment with Bic-CAB will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enzalutamide | Experimental | Drug: EnzalutamideEnzalutamide 160 mg administered orally once a day as four 40-mg soft capsules |
| Flutamide | Active comparator | Drug: FlutamideFlutamide 125 mg administered orally three times a day as one tablet after meal |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Testosterone of less than 50 ng/dL
- Participants who was detected of disease progression on image or relapse of PSA (All PSA values measured 3 time at least one week interval are consecutively increased and final value is 2 ng/mL or more. If third value is not higher than second one, fourth measurement will be undertaken and its value must be higher than second one.)
- Participants who relapsed after CAB with bicalutamide
- Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1
- Aged 20 years or older
Key exclusion criteria (9 listed)
- Any prior treatment with enzalutamide, flutamide, abiraterone or chemotherapy, except for neoadjuvant therapy
- With active double cancer
- Any prior treatment with bicalutamide within 6 weeks
- Participants who received systemic biological therapy (except for existing approved drug for bone or treatment with luteinizing hormone-releasing hormone (LHRH) analogue) or received treatment with other antitumor agent for prostate cancer
- With serious complication
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 |
|---|---|---|
| Enzalutamide | Drug | Enzalutamide |
| Flutamide | Drug | Flutamide |
Primary outcome
Percentage of participants whose prostate specific antigen (PSA) decreased 50 percent or more at month 3
Time frame: Month 3
5 secondary outcomes
Percentage of participants whose PSA decreased 50 percent or more at month 6
Time frame: Month 6
Percentage of participants who showed disease progression at month 3
Time frame: Month 3
Percentage of participants who showed disease progression at month 6
Time frame: Month 6
PSA progression-free survival (PFS)
Time frame: Up to 39 months
QOL measured by functional assessment of cancer therapy-prostate (FACT-P)
Time frame: Up to 39 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Background: PubMed 30971225Iguchi T, Tamada S, Kato M, Yasuda S, Yamasaki T, Nakatani T. Enzalutamide versus flutamide for castration-resistant prostate cancer after combined androgen blockade therapy with bicalutamide: study protocol for a multicenter randomized phase II trial (the OCUU-CRPC study). BMC Cancer. 2019 Apr 11;19(1):339. doi: 10.1186/s12885-019-5526-3.
- Results publication: PubMed 31564004Iguchi T, Tamada S, Kato M, Yasuda S, Machida Y, Ohmachi T, Ishii K, Iwata H, Yamamoto S, Kanamaru T, Morimoto K, Hase T, Tashiro K, Harimoto K, Deguchi T, Adachi T, Iwamoto K, Takegaki Y, Nakatani T. Enzalutamide versus flutamide for castration-resistant prostate cancer after combined androgen blockade therapy with bicalutamide: the OCUU-CRPC study. Int J Clin Oncol. 2020 Mar;25(3):486-494. doi: 10.1007/s10147-019-01554-3. Epub 2019 Sep 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Flutamide in people with Castration-resistant Prostate Cancer, run by Taro Iguchi, MD, PHD at 1 site 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 6 inclusion and 9 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 16 Sep 2021. 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 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of participants whose prostate specific antigen (PSA) decreased 50 percent or more at month 3 (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02346578, which also lists 2 linked publications.
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 16 Sep 2021.