Prostate CancerEarly Phase 1NCT01050842
Bicalutamide and Raloxifene in Treating Patients With Metastatic or Hormone-Refractory Prostate Cancer
A Early Phase 1 study testing bicalutamide, raloxifene and quality-of-life assessment in people with Prostate Cancer and Adenocarcinoma of the Prostate, run by Mayo Clinic at 1 site in United States.
Trial summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Selective estrogen receptor modulators, such as raloxifene, may work together with bicalutamide to stop the growth of 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 the Prostate, Hormone-resistant Prostate Cancer
- What is being tested?
- bicalutamide, raloxifene and quality-of-life assessment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to 4 Oct 2012
- Phase
- Early Phase 1
- 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
- Histological confirmation of prostate adenocarcinoma
- Objective disease progression or rising PSA despite androgen deprivation therapy
- Progression of measurable disease assessed within 28 days prior to registration; progression of non-measurable disease assessed within 28 days prior to registration; patients with rising PSA must demonstrate a rising trend with two successive elevations at a minimum interval of two weeks
- Patients must have been surgically or medically castrated; if the method of castration is LHRH agonists (leuprolide or goserelin) or LHRH antagonists, then the patient should be willing to continue the use of LHRH agonists; castration using LHRH agonist should not be interrupted and patients who have stopped treatment should be willing to restart
- If the patient has been treated with non-steroidal antiandrogens (bicalutamide, flutamide, nilutamide, or ketoconazole) then they must have stopped at least 14 days prior to registration for ketoconazole and at least 28 days prior to registration for bicalutamide, flutamide, or nilutamide and the patients must have demonstrated progression
- Any patient with documented antiandrogen withdrawal syndrome with bicalutamide would not be eligible
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- A minimum PSA of 5 ng/ml or new areas of bony metastases on bone scan are required for patients with no measurable disease; no minimum PSA requirement for patients with measureable disease
- ECOG Performance Status (PS) 0, 1, or 2
- ANC >= 1500
- PLT >= 100,000
- HgB >= 9.0 g/dL
- Total bilirubin =< 1.5 x UNL
- SGOT (AST) =< 3 x UNL
- SGPT (ALT) =< 3 x UNL
- Alkaline Phosphatase =< 3 x UNL
- Creatinine =< 1.5 x UNL
- Ability to complete questionnaire(s) independently or with assistance
- Provide informed written consent
- Willingness to return to Mayo Clinic enrolling institution for follow-up
Who cannot join
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Immunocompromised patients (other than that related to the use of corticosteroids) including patients with known HIV infection
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- Prior radiation therapy is allowed; at least 21 days must have elapsed since completion of radiation therapy, and patients must have recovered from side effects
- Patients may have received prior surgery; at least 21 days must have elapsed since completion of surgery and patient must have recovered from all side effects
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- The use of bisphosphonates is allowed provided that the patient has been receiving that medication for >= 4 weeks with evidence of progressive disease
- Prior systemic therapy to treat prostate cancer including cytotoxic chemotherapy, biologic therapy, vaccine therapy, and experimental therapy is allowed, and at least 28 days must have elapsed since completion of therapy and the patient must have recovered from all side effects
- No concurrent use of estrogen, estrogen-like agents, or other hormonal therapy is allowed; prior use of these agents will need to be discontinued >= 4 weeks prior to registration
- Active other malignancy, except non-melanotic skin cancer or carcinoma-in-situ of the cervix; if there is a history of prior malignancy, must not be receiving other specific treatment (other than hormonal therapy) for cancer
- History of congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- Experienced documented anti-androgen withdrawal syndrome on bicalutamide
- History of venous thromboembolic disease or significant risk for venous thromboembolic disease
- History of symptomatic coronary artery disease
- History of stroke or significant risk for stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Trial to Evaluate the Safety and Efficacy of the Administration of Bicalutamide (Casodex TM) Per Day in Combination With Raloxifene (Evista TM) Per Day in Patients With Hormone Refractory Prostate Cancer
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Selective estrogen receptor modulators, such as raloxifene, may work together with bicalutamide to stop the growth of prostate cancer.
PURPOSE: This clinical trial studies giving bicalutamide and raloxifene together in treating patients with metastatic or hormone-refractory prostate cancer.
Read the detailed description
OBJECTIVES:
- To describe the 6-month progression-free survival rate, progression-free survival, and overall survival of patients receiving bicalutamide and raloxifene.
II. To describe the adverse event profile of combined treatment with bicalutamide and raloxifene (adverse events graded using the NCI CTCAE version 3.0).
III. To describe the quality of life of patients receiving bicalutamide and raloxifene.
OUTLINE: Patients receive oral bicalutamide and oral raloxifene on days 1-28. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3-6 months for up to 3 years.
- Conditions
- Prostate Cancer, Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Stage IV Prostate Cancer
- Being tested
- bicalutamide, raloxifene, quality-of-life assessment
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bicalutamideDrug
Also called Casodex, CDX, Cosudex, ICI 176,334
Given orally
raloxifeneDrug
Also called Evista, Keoxifene, LY 139481, RALOX
Given orally
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary study
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral bicalutamide and oral raloxifene on days 1-28. Receives: Drug: bicalutamide; Drug: raloxifene; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival rate
Measured: 6 months
Adverse events of combined treatment with bicalutamide and raloxifene as measured by CTCAE version 3.0
Quality of life as assessed by Linear Analogue Self Assessment (LASA6) and the Hormonal Domain scale of the Expanded Prostate Cancer Index Composite (EPIC-H) survey
Survival time
Measurable or evaluable disease as assessed by RECIST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2012
- Study completion4 Oct 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 Mayo ClinicThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erik P. Castle, M.D., Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050842
- Sponsor's protocol ID
- MC0851
- Other IDs
- NCI-2009-01700, 07-008912, MC0851
- Status last verified
- Mar 2016
- First submitted
- 14 Jan 2010
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial to Evaluate the Safety and Efficacy of the Administration of Bicalutamide (Casodex TM) Per Day in Combination With Raloxifene (Evista TM) Per Day in Patients With Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT01050842
- Acronym / sponsor ID
- MC0851
- Conditions
- Prostate Cancer, Adenocarcinoma of the Prostate, Hormone-resistant Prostate Cancer, Stage IV Prostate Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2010 (actual)
- Primary completion
- May 2012 (actual)
- Study completion
- 4 Oct 2012 (actual)
- First posted
- 15 Jan 2010 (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.
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Selective estrogen receptor modulators, such as raloxifene, may work together with bicalutamide to stop the growth of prostate cancer.
PURPOSE: This clinical trial studies giving bicalutamide and raloxifene together in treating patients with metastatic or hormone-refractory prostate cancer.
Detailed description
OBJECTIVES:
- To describe the 6-month progression-free survival rate, progression-free survival, and overall survival of patients receiving bicalutamide and raloxifene.
II. To describe the adverse event profile of combined treatment with bicalutamide and raloxifene (adverse events graded using the NCI CTCAE version 3.0).
III. To describe the quality of life of patients receiving bicalutamide and raloxifene.
OUTLINE: Patients receive oral bicalutamide and oral raloxifene on days 1-28. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3-6 months for up to 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: bicalutamide, Drug: raloxifene, Procedure: quality-of-life assessmentPatients receive oral bicalutamide and oral raloxifene on days 1-28. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histological confirmation of prostate adenocarcinoma
- Objective disease progression or rising PSA despite androgen deprivation therapy
- Progression of measurable disease assessed within 28 days prior to registration; progression of non-measurable disease assessed within 28 days prior to registration; patients with rising PSA must demonstrate a rising trend with two successive elevations at a minimum interval of two weeks
- Patients must have been surgically or medically castrated; if the method of castration is LHRH agonists (leuprolide or goserelin) or LHRH antagonists, then the patient should be willing to continue the use of LHRH agonists; castration using LHRH agonist should not be interrupted and patients who have stopped treatment should be willing to restart
- If the patient has been treated with non-steroidal antiandrogens (bicalutamide, flutamide, nilutamide, or ketoconazole) then they must have stopped at least 14 days prior to registration for ketoconazole and at least 28 days prior to registration for bicalutamide, flutamide, or nilutamide and the patients must have demonstrated progression
Key exclusion criteria (15 listed)
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Immunocompromised patients (other than that related to the use of corticosteroids) including patients with known HIV infection
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- Prior radiation therapy is allowed; at least 21 days must have elapsed since completion of radiation therapy, and patients must have recovered from side effects
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 |
|---|---|---|
| bicalutamideAlso: Casodex, CDX, Cosudex, ICI 176,334Given orally | Drug | Arm I |
| raloxifeneAlso: Evista, Keoxifene, LY 139481, RALOXGiven orally | Drug | Arm I |
| quality-of-life assessmentAlso: quality of life assessmentAncillary study | Procedure or surgery | Arm I |
Primary outcome
Progression-free survival rate
Time frame: 6 months
Adverse events of combined treatment with bicalutamide and raloxifene as measured by CTCAE version 3.0
Quality of life as assessed by Linear Analogue Self Assessment (LASA6) and the Hormonal Domain scale of the Expanded Prostate Cancer Index Composite (EPIC-H) survey
Survival time
Measurable or evaluable disease as assessed by RECIST
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 Mar 2017.
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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.
Erik P. Castle, M.D. study chair
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing bicalutamide, raloxifene and quality-of-life assessment in people with Prostate Cancer and Adenocarcinoma of the Prostate, run by Mayo Clinic at 1 site 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 19 inclusion and 15 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 Mar 2017. 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 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Progression-free survival rate (time frame: 6 months). The study lists 5 primary outcomes in all. 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 23 Mar 2017.