Stage I Prostate AdenocarcinomaPhase 2NCT03147196
Bicalutamide and Raloxifene Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery
A Phase 2 study testing Bicalutamide, Laboratory Biomarker Analysis and Questionnaire Administration in people with Stage I Prostate Adenocarcinoma and Stage II Prostate Adenocarcinoma, run by Mayo Clinic.
Trial summary
This phase II pilot trial studies how well bicalutamide and raloxifene hydrochloride work in treating patients with prostate cancer undergoing surgery. Antihormone therapy, such as bicalutamide and raloxifene hydrochloride, may lessen the amount of androgens made by the body. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Stage I Prostate Adenocarcinoma, Stage II Prostate Adenocarcinoma
- What is being tested?
- Bicalutamide, Laboratory Biomarker Analysis and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 27 Jun 2017to Jun 2022
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmation of adenocarcinoma of the prostate, >= Gleason 6, clinical stage T1a-T2c and planned for radical prostatectomy
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- Platelet count >= 50,000/mm^3
- Hemoglobin > 9.0 g/dL
- Creatinine =< 2.0 mg/dL
- Provide informed written consent
- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study); Note: during the Active Monitoring Phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up
- Patients must also provide written consent for biospecimens collection on Institutional Review Board (IRB) 08-000980
Who cannot join
- 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
- History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- History of a venous thromboembolic event, cerebrovascular accident (CVA), hepatic impairment, or heart failure
About this study
Official title: Neoadjuvant Treatment of Prostate Cancer With Bicalutamide and Raloxifene Prior to Radical Prostatectomy
This phase II pilot trial studies how well bicalutamide and raloxifene hydrochloride work in treating patients with prostate cancer undergoing surgery. Antihormone therapy, such as bicalutamide and raloxifene hydrochloride, may lessen the amount of androgens made by the body.
Read the detailed description
PRIMARY OBJECTIVES:
- To collect and interrogate samples in patients with prostate cancer that were diagnosed with prostate cancer and are planned for radical prostatectomy at Mayo Clinic Arizona.
SECONDARY OBJECTIVES:
- To describe the adverse event profile and tolerance of therapy for 60 days of treatment prior to surgery.
II. To assess change in stage and/or grade of cancer and prostate specific antigen (PSA) response to neoadjuvant treatment in patients with hormone sensitive prostate cancer.
TERTIARY OBJECTIVES:
- To evaluate specific pathways and changes when comparing biopsy specimens to prostatectomy.
II. To describe the quality of life of patients receiving hormonal therapy prior to radical prostatectomy.
OUTLINE: This is a dose-escalation study. Patients are randomized to 1 of 4 arms.
ARM A: Patients receive low dose raloxifene hydrochloride orally (PO) daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive low dose bicalutamide PO daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
ARM C: Patients receive low dose raloxifene hydrochloride PO daily and low dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
ARM D: Patients receive high dose raloxifene hydrochloride PO daily and high dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
- Being tested
- Bicalutamide, Laboratory Biomarker Analysis, Questionnaire Administration, Raloxifene Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BicalutamideDrug
Also called Casodex, Cosudex, ICI 176,334, ICI 176334
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
Questionnaire AdministrationOther
Ancillary studies
Raloxifene HydrochlorideDrug
Also called Evista, Keoxifene Hydrochloride, LY-156758, Optruma
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm A (raloxifene hydrochloride) | Experimental | Patients receive low dose raloxifene hydrochloride PO daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Receives: Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Drug: Raloxifene Hydrochloride |
| Arm B (bicalutamide) | Experimental | Patients receive low dose bicalutamide PO daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Bicalutamide; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration |
| Arm C (raloxifene hydrochloride, bicalutamide) | Experimental | Patients receive low dose raloxifene hydrochloride PO daily and low dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Bicalutamide; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Drug: Raloxifene Hydrochloride |
| Arm D (raloxifene hydrochloride, bicalutamide) | Experimental | Patients receive high dose raloxifene hydrochloride PO daily and high dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Bicalutamide; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Drug: Raloxifene Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection and interrogation of prostate cancer samples
Pathways and biomarkers will be compared to similar analyses that have been and will be performed on in vitro and in vivo experiments. Point estimates and two-sided 95% confidence intervals will be computed.
Measured: Up to 5 years
Secondary outcomes (4)
Change in cancer stage/grade via surgical pathology
Will be calculated as the total number who were down staged divided by the number of total evaluable patients. A confidence interval for this rate will be calculated based on properties of the binomial distribution. Point estimates and two-sided 95% confidence intervals will be computed.
Measured: Baseline up to the time of prostatectomy
Incidence of adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns.
Measured: Up to 30 days
Percent change in PSA assessed by Prostate Cancer Clinical Trials Working Group
Will be calculated and displayed using waterfall plots.
Measured: Baseline up to 12 weeks
Tolerance of therapy
Proportion of patients who complete 60 days of treatment will be calculated as the number of who completed 60 days of treatment divided by the total number of evaluable patients. A confidence interval for this rate will be calculated based on properties of the binomial distribution. The proportion of patients who experience a particular event will be calculated as the total number who experienced the event of interest divided by the number of total evaluable patients, with appropriate confidence interval.
Measured: Up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start27 Jun 2017
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I Prostate AdenocarcinomaStudies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Erik Castle, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147196
- Sponsor's protocol ID
- MC1552
- Other IDs
- NCI-2017-00773, MC1552, P30CA015083
- Status last verified
- Jan 2019
- First submitted
- 8 May 2017
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Treatment of Prostate Cancer With Bicalutamide and Raloxifene Prior to Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT03147196
- Acronym / sponsor ID
- MC1552
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 10 May 2017 (actual)
- 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.
This phase II pilot trial studies how well bicalutamide and raloxifene hydrochloride work in treating patients with prostate cancer undergoing surgery. Antihormone therapy, such as bicalutamide and raloxifene hydrochloride, may lessen the amount of androgens made by the body.
Detailed description
PRIMARY OBJECTIVES:
- To collect and interrogate samples in patients with prostate cancer that were diagnosed with prostate cancer and are planned for radical prostatectomy at Mayo Clinic Arizona.
SECONDARY OBJECTIVES:
- To describe the adverse event profile and tolerance of therapy for 60 days of treatment prior to surgery.
II. To assess change in stage and/or grade of cancer and prostate specific antigen (PSA) response to neoadjuvant treatment in patients with hormone sensitive prostate cancer.
TERTIARY OBJECTIVES:
- To evaluate specific pathways and changes when comparing biopsy specimens to prostatectomy.
II. To describe the quality of life of patients receiving hormonal therapy prior to radical prostatectomy.
OUTLINE: This is a dose-escalation study. Patients are randomized to 1 of 4 arms.
ARM A: Patients receive low dose raloxifene hydrochloride orally (PO) daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive low dose bicalutamide PO daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
ARM C: Patients receive low dose raloxifene hydrochloride PO daily and low dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
ARM D: Patients receive high dose raloxifene hydrochloride PO daily and high dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A (raloxifene hydrochloride) | Experimental | Other: Laboratory Biomarker Analysis, Other: Questionnaire Administration, Drug: Raloxifene HydrochloridePatients receive low dose raloxifene hydrochloride PO daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. |
| Arm B (bicalutamide) | Experimental | Drug: Bicalutamide, Other: Laboratory Biomarker Analysis, Other: Questionnaire AdministrationPatients receive low dose bicalutamide PO daily on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. |
| Arm C (raloxifene hydrochloride, bicalutamide) | Experimental | Drug: Bicalutamide, Other: Laboratory Biomarker Analysis, Other: Questionnaire Administration, Drug: Raloxifene HydrochloridePatients receive low dose raloxifene hydrochloride PO daily and low dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. |
| Arm D (raloxifene hydrochloride, bicalutamide) | Experimental | Drug: Bicalutamide, Other: Laboratory Biomarker Analysis, Other: Questionnaire Administration, Drug: Raloxifene HydrochloridePatients receive high dose raloxifene hydrochloride PO daily and high dose bicalutamide PO on days 1-30. Treatment repeats every 30 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histological confirmation of adenocarcinoma of the prostate, >= Gleason 6, clinical stage T1a-T2c and planned for radical prostatectomy
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- Platelet count >= 50,000/mm^3
- Hemoglobin > 9.0 g/dL
- Creatinine =< 2.0 mg/dL
Key exclusion criteria (4 listed)
- 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
- History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- History of a venous thromboembolic event, cerebrovascular accident (CVA), hepatic impairment, or heart failure
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, Cosudex, ICI 176,334, ICI 176334Given PO | Drug | Arm B (bicalutamide), Arm C (raloxifene hydrochloride, bicalutamide), Arm D (raloxifene hydrochloride, bicalutamide) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm A (raloxifene hydrochloride), Arm B (bicalutamide), Arm C (raloxifene hydrochloride, bicalutamide), Arm D (raloxifene hydrochloride, bicalutamide) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (raloxifene hydrochloride), Arm B (bicalutamide), Arm C (raloxifene hydrochloride, bicalutamide), Arm D (raloxifene hydrochloride, bicalutamide) |
| Raloxifene HydrochlorideAlso: Evista, Keoxifene Hydrochloride, LY-156758, OptrumaGiven PO | Drug | Arm A (raloxifene hydrochloride), Arm C (raloxifene hydrochloride, bicalutamide), Arm D (raloxifene hydrochloride, bicalutamide) |
Primary outcome
Collection and interrogation of prostate cancer samples
Time frame: Up to 5 years
Pathways and biomarkers will be compared to similar analyses that have been and will be performed on in vitro and in vivo experiments. Point estimates and two-sided 95% confidence intervals will be computed.
4 secondary outcomes
Change in cancer stage/grade via surgical pathology
Time frame: Baseline up to the time of prostatectomy
Incidence of adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time frame: Up to 30 days
Percent change in PSA assessed by Prostate Cancer Clinical Trials Working Group
Time frame: Baseline up to 12 weeks
Tolerance of therapy
Time frame: Up to 60 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
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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 Castle principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bicalutamide, Laboratory Biomarker Analysis and Questionnaire Administration in people with Stage I Prostate Adenocarcinoma and Stage II Prostate Adenocarcinoma, run by Mayo Clinic.
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 8 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: withdrawn, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Collection and interrogation of prostate cancer samples (time frame: Up to 5 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 22 Jan 2019.