Prostate CancerPhase 2NCT00140478
Mifepristone (RU-486) in Androgen Independent Prostate Cancer
A Phase 2 study testing Mifepristone in people with Prostate Cancer and Adenocarcinoma of Prostate, run by Dana-Farber Cancer Institute at 4 sites in United States.
Trial summary
The purpose of this study is to determine the effects (good and bad) that mifepristone has on patients with androgen independent prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Adenocarcinoma of Prostate
- What is being tested?
- Mifepristone
- Type of treatment
- Pill or oral medicine
- How many people
- 48 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 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
- Histologic documentation of adenocarcinoma of the prostate
- Bone metastasis(es) by bone scan or cat scan
- Clinical, biochemical, or radiographic progression after primary androgen ablation with either orchiectomy or gonadotropin releasing hormone analog therapy.
- One prior chemotherapy treatment is allowed.
- > 3 weeks since major surgery
- > 4 weeks since radiotherapy
Show all 16Show fewer
- > 8 weeks since prior strontium-89 or samarium 153
- ECOG performance status 0 or 1
- Absolute neutrophil count (ANC) > 1,500/ul
- Platelets > 100,000/ul
- Bilirubin < 1.5 x upper limit of normal (ULN)
- AST or ALT < 3 x ULN
- Creatinine < 1.5 x ULN
- Electrolytes within 10% of normal range
- Serum testosterone < 50ng/dL
- Prostate-specific antigen (PSA) > 5.0ng/ml
Who cannot join
- Concomitant therapy with corticosteroids
- Chemotherapy within 28 days
- Currently active second malignancy other than non-melanoma skin cancer
- Baseline adrenal insufficiency requiring long-term steroids
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02115
Georgetown University
Washington D.C., District of Columbia, 20057
About this study
Official title: A Phase II Study of Mifepristone (RU-486) in Androgen Independent Prostate Cancer With Correlative Assessment of Androgen Receptor Co-Repressor Proteins
The purpose of this study is to determine the effects (good and bad) that mifepristone has on patients with androgen independent prostate cancer.
Read the detailed description
Patients will receive mifepristone, 200mg orally once a day. One treatment cycle is 28 days long. Patients will remain on treatment unless their cancer gets worse or they develop intolerable side effects.
At the end of each cycle a physical examination, routine blood tests, and hormone levels will be performed.
After every 3 cycles, one or more of the following will be performed: bone scan, chest x-ray, CT scan or MRI.
- Conditions
- Prostate Cancer, Adenocarcinoma of Prostate
- Being tested
- Mifepristone
- Keywords
- Androgen Independent Prostate Cancer, Prostate Cancer, Mifepristone, RU-486
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Also called RU-486
200mg orally once daily
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the therapeutic efficacy of mifepristone in patients with androgen independent prostate cancer
Measured: 2 years
Secondary outcomes (1)
To determine the duration of response, time to disease progression and safety of mifepristone in patients with androgen independent prostate cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionJun 2006
- 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.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Brigham and Women's Hospital, Georgetown University
- Investigators
- Mary-Ellen Taplin, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140478
- Sponsor's protocol ID
- 04-249
- Status last verified
- Dec 2009
- First submitted
- 30 Aug 2005
- Last updated
- 9 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Mifepristone (RU-486) in Androgen Independent Prostate Cancer With Correlative Assessment of Androgen Receptor Co-Repressor Proteins
- ClinicalTrials.gov ID
- NCT00140478
- Acronym / sponsor ID
- 04-249
- Conditions
- Prostate Cancer, Adenocarcinoma of Prostate
- Keywords
- Androgen Independent Prostate Cancer, Prostate Cancer, Mifepristone, RU-486
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Brigham and Women's Hospital, Georgetown University
- Study start
- Feb 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 1 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.
The purpose of this study is to determine the effects (good and bad) that mifepristone has on patients with androgen independent prostate cancer.
Detailed description
Patients will receive mifepristone, 200mg orally once a day. One treatment cycle is 28 days long. Patients will remain on treatment unless their cancer gets worse or they develop intolerable side effects.
At the end of each cycle a physical examination, routine blood tests, and hormone levels will be performed.
After every 3 cycles, one or more of the following will be performed: bone scan, chest x-ray, CT scan or MRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologic documentation of adenocarcinoma of the prostate
- Bone metastasis(es) by bone scan or cat scan
- Clinical, biochemical, or radiographic progression after primary androgen ablation with either orchiectomy or gonadotropin releasing hormone analog therapy.
- One prior chemotherapy treatment is allowed.
- > 3 weeks since major surgery
Key exclusion criteria (4 listed)
- Concomitant therapy with corticosteroids
- Chemotherapy within 28 days
- Currently active second malignancy other than non-melanoma skin cancer
- Baseline adrenal insufficiency requiring long-term steroids
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 |
|---|---|---|
| MifepristoneAlso: RU-486200mg orally once daily | Drug | – |
Primary outcome
To determine the therapeutic efficacy of mifepristone in patients with androgen independent prostate cancer
Time frame: 2 years
1 secondary outcome
To determine the duration of response, time to disease progression and safety of mifepristone in patients with androgen independent prostate cancer
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 9 Dec 2009.
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.
Mary-Ellen Taplin, MD principal investigator
Dana-Farber Cancer Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mifepristone in people with Prostate Cancer and Adenocarcinoma of Prostate, run by Dana-Farber Cancer Institute at 4 sites in United States.
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 16 inclusion and 4 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 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
To determine the therapeutic efficacy of mifepristone in patients with androgen independent prostate cancer (time frame: 2 years). 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 2009.