Prostate CancerCAMONNCT00919477

Protocol for the Specified Clinical Experience Investigation on the Single Use of Casodex® Tablet 80 mg

An observational study of Prostate Cancer, run by AstraZeneca at 160 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To gather information on the safety of monotherapy of Casodex® tablets 80 mg, targeting prostate cancer patients who have no history of having received treatment by either endocrine therapy (including surgical castration). Read more about this study

Who is it for?: Any age, men only
Conditions the study is for: Prostate Cancer
How many people: 712 participants
Where: 160 sitesJapan
Study dates: May 2009to Mar 2012
Phase: Observational
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 Any age
Men only
No healthy volunteers
Child, Adult, Older adult

Study population: Prostate cancer patients who have no history of having received treatment by either endocrine therapy (including surgical castration)

Who may be able to join

Prostate cancer patients who have no history of receiving endocrine therapy (including surgical castration), and who plan to undergo Casodex® tablets monotherapy for not less than 12 months

Who cannot join

None listed.

Trial locations and contacts

160 sites in 1 country.

City, postcode or hospital

160 sites in 1 country

Japan160 sites

Research Site
Adachi City, Tokyo
Research Site
Aizu-Wakamatsu, Fukushima
Research Site
Akashi, Hyōgo
Research Site
Akita, Akita
Research Site
Arakawa City, Tokyo
Research Site
Asagiri, Saitama
Research Site
Asahi, Chiba
Research Site
Asahikawa, Hokkaido
Research Site
Ashikaga, Tochigi
Research Site
Atsugi, Kanagawa
Research Site
Chigasaki, Kanagawa
Research Site
Chikushino-shi, Fukuoka
Research Site
Chiyoda City, Tokyo
Research Site
Ebina, Kanagawa
Research Site
Edogawa City, Tokyo
Research Site
Eniwa, Hokkaido
Research Site
Fuji, Shizuoka
Research Site
Fujieda, Shizuoka
Research Site
Fukuoka, Fukuoka
Research Site
Fukushima, Fukushima
Research Site
Funahashi, Chiba
Research Site
Gifu, Gifu
Research Site
Gosen, Niigata
Research Site
Habikino, Osaka
Research Site
Hakusan, Ishihawa
Research Site
Hamada, Shimane
Research Site
Hamamatsu, Shizuoka
Research Site
Hidaka, Saitama
Research Site
Hirosaki, Aomori
Research Site
Hiroshima, Hiroshima
Research Site
Hitachi, Ibaraki
Research Site
Hizume, Iwate
Research Site
Houmei, Aichi-ken
Research Site
Ibaraki, Osaka
Research Site
Ibi, Gifu
Research Site
Ichihara, Chiba
Research Site
Ichikawa, Chiba
Research Site
Ichinoseki, Iwate
Research Site
Iizuka, Fukuoka
Research Site
Ikeda, Osaka
Research Site
Ikoma, Nara
Research Site
Imabari, Ehime
Research Site
Inabe, Mie-ken
Research Site
Inuyama, Aichi-ken
Research Site
Isahaya, Nagasaki
Research Site
Isesaki, Gunma
Research Site
Izu, Shizuoka
Research Site
Izumisano, Osaka
Research Site
Kai, Yamanashi
Research Site
Kaizuka, Osaka
Research Site
Kamaishi, Iwate
Research Site
Kani, Gifu
Research Site
Kashiba, Nara
Research Site
Kasuga, Fukuoka
Research Site
Kasugai, Aichi-ken
Research Site
Katou, Hyōgo
Research Site
Katsushika-ku, Tokyo
Research Site
Kawagoe, Saitama
Research Site
Kawasaki, Kanagawa
Research Site
Kiryū, Gunma
Research Site
Kishiwada, Osaka
Research Site
Kitakyushu, Fukuoka
Research Site
Kobe, Hyōgo
Research Site
Kochi, Kochi
Research Site
Koshigaya, Saitama
Research Site
Koutou, Tokyo
Research Site
Kumagaya, Saitama
Research Site
Kumamoto, Kumamoto
Research Site
Kurashiki, Okayama-ken
Research Site
Kurobe-shi, Toyama
Research Site
Kurume, Fukuoka
Research Site
Kushiro, Hokkaido
Research Site
Kyoto, Kyoto
Research Site
Matsubara, Osaka
Research Site
Matsushima, Miyagi
Research Site
Matsuyama, Ehime
Research Site
Minamisatsuma, Kagoshima-ken
Research Site
Minato, Tokyo
Research Site
Minoh, Osaka
Research Site
Minokamo, Gifu
Research Site
Mito, Ibaraki
Research Site
Miyako, Iwate
Research Site
Mizunami, Gifu
Research Site
Morioka, Iwate
Research Site
Motiguchi, Osaka
Research Site
Musashino, Tokyo
Research Site
Nagasaki, Nagasaki
Research Site
Nagoya, Aichi-ken
Research Site
Nakano City, Tokyo
Research Site
Nakatsu, Oita Prefecture
Research Site
Nantan, Kyoto
Research Site
Nara, Nara
Research Site
Narashino, Chiba
Research Site
Natori-shi, Miyagi
Research Site
Neyagawa, Osaka
Research Site
Niihama, Ehime
Research Site
Nirasaki, Yamanashi
Research Site
Nishitōkyō, Tokyo
Research Site
Numata, Gunma
Research Site
Ōdate, Akita
Research Site
Ōgaki, Gifu
Research Site
Ohta, Gunma
Research Site
Okayama, Okayama-ken
Research Site
Okazaki, Aichi-ken
Research Site
Oota, Tokyo
Research Site
Osaka, Osaka
Research Site
Ōsaka-sayama, Osaka
Research Site
Ōta-ku, Tokyo
Research Site
Sagamihara, Kanagawa
Research Site
Saitama, Saitama
Research Site
Sakai, Osaka
Research Site
Sakura, Chiba
Research Site
Sapporo, Hokkaido
Research Site
Sasebo, Nagasaki
Research Site
Sashima, Ibaraki
Research Site
Sayama, Saitama
Research Site
Sekimachi, Gifu
Research Site
Sendai, Miyagi
Research Site
Setagaya City, Tokyo
Research Site
Shibuya City, Tokyo
Research Site
Shimizu, Shizuoka
Research Site
Shinagawa, Tokyo
Research Site
Shinjyuku, Tokyo
Research Site
Shiogama, Miyagi
Research Site
Shizuoka, Shizuoka
Research Site
Suita, Osaka
Research Site
Sumida City, Tokyo
Research Site
Sunagawa, Hokkaido
Research Site
tabashi City, Tokyo
Research Site
Tachikawa, Tokyo
Research Site
Tagajō-shi, Miyagi
Research Site
Takamatsu, Kagawa-ken
Research Site
Takaoka, Toyama
Research Site
Takarazuka, Hyōgo
Research Site
Takasaki, Gunma
Research Site
Tokushima, Tokushima
Research Site
Tomakomai, Hokkaido
Research Site
Toride, Ibaraki
Research Site
Toshima City, Tokyo
Research Site
Tottori-shi, Tottori
Research Site
Toyama, Toyama
Research Site
Toyohashi, Aichi-ken
Research Site
Toyonaka, Osaka
Research Site
Toyota, Aichi-ken
Research Site
Tsu, Mie-ken
Research Site
Tsubame, Niigata
Research Site
Tsuchiura, Ibaraki
Research Site
Uwajima, Ehime
Research Site
Wakayama, Wakayama
Research Site
Yachi, Yamagata
Research Site
Yamagata, Gifu
Research Site
Yamagata, Yamagata
Research Site
Yamato, Kanagawa
Research Site
Yao, Osaka
Research Site
Yokohama, Kanagawa
Research Site
Yokosuka, Kanagawa
Research Site
Yoshinogawa, Tokushima
Research Site
Yourou, Gifu
Research Site
Yukuhashi, Fukuoka
Research Site
Zentrsuji, Kagawa-ken

Other trials in Japan

About this study

Conditions: Prostate Cancer
Keywords: Prostate cancer, Casodex, Monotherapy
Medical subject headings: Prostatic Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse event incidence
Measured: Time since starting Casodex monotherapy, monthly

Secondary outcomes (2)

improvement of prostate cancer using Tumor marker PSA
Measured: Time since starting Casodex monotherapy, monthly
Maintenance of sexual function
Measured: At 3 months since starting Casodex monotherapy,

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Mar 2012

First posted12 Jun 2009 (estimated)
Study startMay 2009
Primary completionMar 2012
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 712 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00919477
Sponsor's protocol ID: NIS-OJP-CAS-2009/1
Other IDs: CAS002
Acronym: CAMON
Status last verified: Jan 2013
First submitted: 11 Jun 2009
Last updated: 23 Jan 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Active, not recruitingPhase 3
Stereotactic Body Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Stage IIA-B Prostate Cancer
Stage II Prostate Adenocarcinoma AJCC v7
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
RecruitingPhase 1
Pilot Study for Detection of PSMA-Low CRPC-NE Tumors With Fluciclovine PET/CT
Advanced Prostate Cancer, Metastatic Prostate Cancer
RecruitingPhase 1
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
Prostate Cancer, Metastatic Castration-resistant Prostate Cancer

All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Protocol for the Specified Clinical Experience Investigation on the Single Use of Casodex® Tablet 80 mg
ClinicalTrials.gov ID: NCT00919477
Acronym / sponsor ID: CAMON / NIS-OJP-CAS-2009/1
Conditions: Prostate Cancer
Keywords: Prostate cancer, Casodex, Monotherapy
Study type: Observational
Recruitment status: Completed
Enrolment: 712 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: May 2009
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 12 Jun 2009 (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.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Prostate cancer patients who have no history of having received treatment by either endocrine therapy (including surgical castration)

Key inclusion criteria (1 listed)

Prostate cancer patients who have no history of receiving endocrine therapy (including surgical castration), and who plan to undergo Casodex® tablets monotherapy for not less than 12 months

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Adverse event incidence
Time frame: Time since starting Casodex monotherapy, monthly

2 secondary outcomes

improvement of prostate cancer using Tumor marker PSA
Time frame: Time since starting Casodex monotherapy, monthly
Maintenance of sexual function
Time frame: At 3 months since starting Casodex monotherapy,

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 23 Jan 2013.

Related trials for Prostate Cancer

Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Active, not recruitingPhase 3
Stereotactic Body Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Stage IIA-B Prostate Cancer
Stage II Prostate Adenocarcinoma AJCC v7
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
RecruitingPhase 1
Pilot Study for Detection of PSMA-Low CRPC-NE Tumors With Fluciclovine PET/CT
Advanced Prostate Cancer, Metastatic Prostate Cancer
RecruitingPhase 1
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
Prostate Cancer, Metastatic 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.

The record lists no contact. Use the official record to reach the sponsor.

160 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer, run by AstraZeneca at 160 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 1 inclusion and 0 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 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 160 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.

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?

Adverse event incidence (time frame: Time since starting Casodex monotherapy, monthly). 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 NCT00919477.

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 23 Jan 2013.