Prostate CancerPhase 2NCT00196339

A Clinical Trial to Study DR-2031 for the Treatment of Hot Flashes in Prostate Cancer Patients

A Phase 2 study testing Cyproterone acetate 5, Cyproterone acetate 15 and Cyproterone acetate 25 in people with Prostate Cancer, run by Duramed Research at 118 sites in 2 countries.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: Cyproterone acetate 5, Cyproterone acetate 15 and Cyproterone acetate 25
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 315 participants
Where: 118 sitesin 2 countries
Study dates: Jun 2005to Jan 2008
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 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Prostate cancer patients who have undergone chemical or surgical castration
History of hot flashes for at least 30 days
Stable prostate cancer therapy for at least 45 days

Who cannot join

Uncontrolled diabetes or severe COPD
History of thromboembolic disease
Liver or kidney dysfunction
History or presence of cancer other than prostate cancer within the last 5 years
Surgery within the last 3 months

Trial locations and contacts

118 sites in 2 countries.

Country

City, postcode or hospital

118 sites in 2 countries

United States98 sites

Duramed Investigational Site
Albany, New York, 12208
Duramed Investigational Site
Allentown, Pennsylvania, 18103
Duramed Investigational Site
Anaheim, California, 92801
Duramed Investigational Site
Asheboro, North Carolina, 27203
Duramed Investigational site
Atlanta, Georgia, 30342
Duramed Investigational Site
Austin, Texas, 78705
Duramed Investigational Site
Aventura, Florida, 33180
Duramed Investigational Site
Bala-Cynwyd, Pennsylvania, 19004
Duramed Investigational Site
Bay Shore, New York, 11706
Duramed Investigational Site
Berwyn, Illinois, 60402
Duramed Investigational Site
Bethany, Oklahoma, 73008
Duramed Investigational Site
Birmingham, Alabama, 35209
Duramed Investigational Site
Birmingham, Alabama, 35234
Duramed Investigational Site
Brick, New Jersey, 08724
Duramed Investigational Site
Canfield, Ohio, 44406
Duramed Investigational Site
Canton, Ohio, 44718
Duramed Investigational Site
Charleston, South Carolina, 29425
Duramed Investigational Site
Chicago, Illinois, 60640
Duramed Investigational Site
Cincinnati, Ohio, 45212
Duramed Investigational Site
Coeur d'Alene, Idaho, 83814
Duramed Investigational Site
Concord, North Carolina, 28025
Duramed Investigational Site
Dallas, Texas, 75231
Duramed Investigational Site
Daytona Beach, Florida, 32114
Duramed Investigational Site
Denver, Colorado, 80210
Duramed Investigational Site
Denver, Colorado, 80211
Duramed Investigational Site
Des Moines, Iowa, 50309
Duramed Investigational Site
Edison, New Jersey, 08837
Duramed Investigational Site
Elmont, New York, 11003
Duramed Investigational Site
Fargo, North Dakota, 58104
Duramed Investigational Site
Fresno, California, 93720
Duramed Investigational site
Garden City, New York, 11530
Duramed Investigational Site
Greenbelt, Maryland, 20770
Duramed Investigational Site
Greenwood, Indiana, 46143
Duramed Investigational Site
Homewood, Alabama, 35209
Duramed Investigational Site
Houston, Texas, 77074
Duramed Investigational Site
Huntsville, Alabama, 35801
Duramed Investigational Site
Jackson, Mississippi, 39202
Duramed Investigational Site
Jeffersonville, Indiana, 47130
Duramed Investigational Site
Kankakee, Illinois, 60901
Duramed Investigational Site
Knoxville, Tennessee, 37920
Duramed Investigational Site
La Mesa, California, 91942
Duramed Investigational Site
Laguna Hills, California, 92653
Duramed Investigational Site
Laguna Woods, California, 92637
Duramed Investigational Site
Lancaster, Pennsylvania, 17604
Duramed Investigational Site
Las Vegas, Nevada, 89109
Duramed Investigational Site
Lawrenceville, New Jersey, 08648
Duramed Investigational Site
Little Rock, Arkansas, 72211
Duramed Investigational Site
Long Beach, California, 90806
Duramed Investigational Site
Los Angeles, California, 90048
Duramed Investigational Site
Middlebury, Connecticut, 06762
Duramed Investigational Site
Milwaukee, Wisconsin, 53209
Duramed Investigational Site
New Britain, Connecticut, 06052
Duramed Investigational Site
New Orleans, Louisiana, 70121
Duramed Investigational Site
New Port Richey, Florida, 34652
Duramed Investigational Site
New York, New York, 10016
Duramed Investigational Site
Newton, Massachusetts, 02462
Duramed Investigational Site
Ocala, Florida, 34470
Duramed Investigational Site
Ocala, Florida, 34471
Duramed Investiational Site
Ocala, Florida, 34474
Duramed Investigational Site
Oklahoma City, Oklahoma, 73112
Duramed Investigational Site
Overland Park, Kansas, 66211
Duramed Investigational Site
Peoria, Illinois, 61614
Duramed Investigational Site
Philadelphia, Pennsylvania, 19115
Duramed Investigational Site
Phoenix, Arizona, 85013
Duramed Investigational Site
Pittsburgh, Pennsylvania, 15212
Duramed Investigational Site
Pittsburgh, Pennsylvania, 15232
Duramed Investigational Site
Plantation, Florida, 33324
Duramed Investigational Site
Poughkeepsie, New York, 12601
Duramed Investigational Site
Providence, Rhode Island, 02904
Duramed Investigational Site
Raleigh, North Carolina, 27607
Duramed Investigational Site
Richmond, Virginia, 23235
Duramed Investigational Site
Saint Joseph, Michigan, 49085
Duramed Investigational Site
Salt Lake City, Utah, 84107
Duramed Investigational Site
Salt Lake City, Utah, 84124
Duramed Investigational Site
San Antonio, Texas, 78229
Duramed Investigational Site
San Bernardino, California, 92404
Duramed Investigational Site
San Diego, California, 92103
Duramed Investigational Site
Sarasota, Florida, 34237
Duramed Investigational Site
Sartell, Minnesota, 56377
Duramed Investigational Site
Seattle, Washington, 98166
Duramed Investigational Site
Sellersville, Pennsylvania, 18960
Duramed Investigational Site
Shreveport, Louisiana, 71106
Duramed Investigational Site
Spring Hill, Florida, 34608
Duramed Investigational Site
St Louis, Missouri, 63141
Duramed Investigational Site
St. Petersburg, Florida, 33703
Duramed Investigational Site
St. Petersburg, Florida, 33710
Duramed Investigational Site
State College, Pennsylvania, 16801
Duramed Investigational Site
Staten Island, New York, 10304
Duramed Investigational Site
Tacoma, Washington, 98405
Duramed Investigational Site
Tacoma, Washington, 98431
Duramed Investigational Site
Torrance, California, 90505
Duramed Investigational Site
Trumbull, Connecticut, 06611
Duramed Investigational Site
Tucson, Arizona, 85712
Duramed Investigational Site
Washington D.C., District of Columbia, 20307
Duramed Investigational Site
Waterbury, Connecticut, 06708
Duramed Investigational Site
Watertown, Massachusetts, 02472
Duramed Investigational Site
Wheat Ridge, Colorado, 80033
Duramed Investigational Site
Williamsville, New York, 14221

Other trials in United States

Canada20 sites

Duramed Investigational Site
Barrie, Ontario, L4M 7G1
Duramed Investigational Site
Brantford, Ontario, N3R 4N3
Duramed Investigational Site
Greater Sudbury, Ontario, P3E 4T3
Duramed Investigational Site
Guelph, Ontario, N1H 5J2
Duramed Investigational Site
Kelowna, British Columbia, V1Y 2H4
Duramed Investigational Site
Kentville, Nova Scotia, B4N 4K9
Duramed Investigational Site
Markham, Ontario, L6B 1A1
Duramed Investigational Site
Mirabel, Quebec, J7J 2K8
Duramed Investigational Site
North Bay, Ontario, P1B 4Z2
Duramed Investigational Site
Oakville, Ontario, L6H 3P1
Duramed Investigational Site
Oshawa, Ontario, L1H 1B9
Duramed Investigational Site
Ottawa, Ontario, K1H 8L6
Duramed Investigational Site
Pointe-Claire, Quebec, H9R 4S3
Duramed Investigational Site
Saint John, New Brunswick, E2L 3J8
Duramed Investigational Site
Surrey, British Columbia, V3V 1N1
Duramed Investigational Site
Toronto, Ontario, M1P 2T7
Duramed Investigational Site
Toronto, Ontario, M6A 3B5
Duramed Investigational Site
Vancouver, British Columbia, V5Z 1M9
Duramed Investigational Site
Vancouver, British Columbia, V5Z 4E6
Duramed Investigational Site
Victoria, British Columbia, V8V 3N1

Other trials in Canada

About this study

Official title: A Dose-ranging Clinical Trial to Study the Efficacy and Safety of DR-2031 for the Treatment of Hot Flashes Following Surgical or Medical Castration of Prostate Cancer Patients

This is a study to compare the efficacy and safety of 3 doses of DR-2031 to placebo when used as "add-on" therapy for prostate cancer patients with hot flashes following surgical or medical castration. All prostate cancer therapy must be stable for at least 45 days before entering the study and must remain stable throughout this 12-week study. Patients will maintain a daily paper diary to record the frequency and severity of hot flashes during the treatment period.

Read the detailed description

This is a study to compare the efficacy and safety of 3 doses of DR-2031 to placebo when used as "add-on" therapy for prostate cancer in patients with mild to moderate vasomotor symptoms (hot flashes) following surgical or medical castration. All prostate cancer therapy must be stable for at least 45 days before entering the study and must remain stable throughout this 12-week study. To be eligible for this study prostate cancer patients must have undergone bilateral orchiectomy or medical castration utilizing LHRH analogues (LHRH agonists or LHRH antagonists) with or without additional antiandrogen therapy. Patients must have at least 21 moderate to severe hot flashes weekly.

Patients will maintain a daily paper diary to record the frequency and severity of hot flashes during the treatment period. In addition, a brief physical evaluation will be done, diaries will be reviewed and any adverse events will be recorded at each follow-up evaluation.

Conditions: Prostate Cancer
Being tested: Cyproterone acetate 5, Placebo, Cyproterone acetate 15, Cyproterone acetate 25
Keywords: prostate cancer, hot flashes, hot flushes, vasomotor symptoms
Medical subject headings: Prostatic Neoplasms, Hot Flashes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cyproterone acetate 5Drug
Also called DR-2031
Cyproterone acetate 5 mg
PlaceboDrug
Matching placebo
Cyproterone acetate 15Drug
Also called DR-2031
Cyproterone acetate 15 mg
Cyproterone acetate 25Drug
Also called DR-2031
Cyproterone acetate 25 mg

Study groups in NCT00196339
Study group	Role	What they receive
Cyproterone acetate 5 mg ( DR-2031)	Experimental	1 tablet daily Receives: Drug: Cyproterone acetate 5
Cyproterone acetate 15 mg ( DR-2031)	Experimental	1 tablet daily Receives: Drug: Cyproterone acetate 15
Cyproterone acetate 25 mg ( DR-2031)	Experimental	1 tablet daily Receives: Drug: Cyproterone acetate 25
Placebo	Placebo comparator	1 tablet daily Receives: Drug: Placebo

What is being measured

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

To compare the efficacy in reducing the frequency and severity of moderate to severe hot flashes
Measured: Throughout study
To evaluate the safety compared to placebo
Measured: Throughout study
Identify the lowest effective dose.
Measured: End of study

Secondary outcomes (2)

To compare the efficacy in reducing the severity of all hot flashes
Measured: Throughout study
To compare the efficacy in elimination of all hot flashes
Measured: Throughout study

Timeline

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

Jun 2005Jan 2008

First posted20 Sep 2005 (estimated)
Study startJun 2005
Primary completionJan 2008
Study completionJan 2008

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.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 315 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00196339
Sponsor's protocol ID: DR-PCA-201
Status last verified: Jul 2016
First submitted: 12 Sep 2005
Last updated: 22 Jul 2016
Results posted: No
Data monitoring committee: Yes

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

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STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose-ranging Clinical Trial to Study the Efficacy and Safety of DR-2031 for the Treatment of Hot Flashes Following Surgical or Medical Castration of Prostate Cancer Patients
ClinicalTrials.gov ID: NCT00196339
Acronym / sponsor ID: DR-PCA-201
Conditions: Prostate Cancer
Keywords: prostate cancer, hot flashes, hot flushes, vasomotor symptoms
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 315 participants (actual)
Lead sponsor: Duramed ResearchIndustry (pharma, biotech, devices)
Study start: Jun 2005
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 20 Sep 2005 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Cyproterone acetate 5 mg ( DR-2031)	Experimental	Drug: Cyproterone acetate 51 tablet daily
Cyproterone acetate 15 mg ( DR-2031)	Experimental	Drug: Cyproterone acetate 151 tablet daily
Cyproterone acetate 25 mg ( DR-2031)	Experimental	Drug: Cyproterone acetate 251 tablet daily
Placebo	Placebo comparator	Drug: Placebo1 tablet daily

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Prostate cancer patients who have undergone chemical or surgical castration
History of hot flashes for at least 30 days
Stable prostate cancer therapy for at least 45 days

Key exclusion criteria (5 listed)

Uncontrolled diabetes or severe COPD
History of thromboembolic disease
Liver or kidney dysfunction
History or presence of cancer other than prostate cancer within the last 5 years
Surgery within the last 3 months

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
Cyproterone acetate 5Also: DR-2031Cyproterone acetate 5 mg	Drug	Cyproterone acetate 5 mg ( DR-2031)
PlaceboMatching placebo	Drug	Placebo
Cyproterone acetate 15Also: DR-2031Cyproterone acetate 15 mg	Drug	Cyproterone acetate 15 mg ( DR-2031)
Cyproterone acetate 25Also: DR-2031Cyproterone acetate 25 mg	Drug	Cyproterone acetate 25 mg ( DR-2031)

Primary outcome

To compare the efficacy in reducing the frequency and severity of moderate to severe hot flashes
Time frame: Throughout study
To evaluate the safety compared to placebo
Time frame: Throughout study
Identify the lowest effective dose.
Time frame: End of study

2 secondary outcomes

To compare the efficacy in reducing the severity of all hot flashes
Time frame: Throughout study
To compare the efficacy in elimination of all hot flashes
Time frame: Throughout study

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 22 Jul 2016.
MedLine Plus - Prostate CancerLink provided by the sponsor.

Related trials for Prostate Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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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.

Duramed Protocol Chair study chair

Duramed Research, Inc.

118 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cyproterone acetate 5, Cyproterone acetate 15 and Cyproterone acetate 25 in people with Prostate Cancer, run by Duramed Research at 118 sites in 2 countries.

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 3 inclusion and 5 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 22 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States, Canada. 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. Some participants in this study may receive a placebo. 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?

To compare the efficacy in reducing the frequency and severity of moderate to severe hot flashes (time frame: Throughout study). The study lists 3 primary outcomes in all. 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 NCT00196339.

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 22 Jul 2016.