Prostate AdenocarcinomaPhase 2NCT01325311
Cholecalciferol and Genistein Before Surgery in Treating Patients With Early Stage Prostate Cancer
A Phase 2 study testing Cholecalciferol, Genistein and Laboratory Biomarker Analysis in people with Prostate Adenocarcinoma and Stage I Prostate Cancer, run by National Cancer Institute (NCI) at 11 sites in United States.
Trial summary
This randomized phase II trial studies cholecalciferol and genistein compared to placebo in treating patients with early stage prostate cancer. Cholecalciferol and genistein may slow the growth of cancer cells and may be an effective treatment for prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma, Stage I Prostate Cancer, Stage IIA Prostate Cancer
- What is being tested?
- Cholecalciferol, Genistein and Laboratory Biomarker Analysis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 11 sitesUnited States
- Study dates
- Dec 2011to Jul 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants must have microscopic confirmation of adenocarcinoma of the prostate within three months of randomization; clinical stage T1 and T2 a, b, or c are allowed
- Participants' prostate cancer must be confined to the prostate (in the clinical judgment of the treating physician)
- Participants must be candidates for prostatectomy
- Participants must have Eastern Cooperative Oncology Group (ECOG) performance status =<1 (Karnofsky >= 70%)
- White blood cell (WBC) within normal limits
- Platelets >= 100 K/uL
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- Hemoglobin >= 10 g/dL
- Thyroid-stimulating hormone (TSH) =< 4.20 uIU/mL
- Free T4 =< 12.5 ng/dL
- Bilirubin within upper limit of normal
- Aspartate aminotransferase (AST) =< 1.5 x upper limit of normal
- Creatinine =< 2.0 mg/dL
- Serum calcium: within institutional normal limits
- Participants must agree to stop taking nonsteroidal anti-inflammatory drugs (NSAIDS) during the course of the study, however, low dose aspirin (< 100 mg/day) will be allowed; no wash out period is required
- Participants must be willing to discontinue consuming soy products and ingesting vitamin supplements while participating in this study
- The effects of cholecalciferol and genistein on the developing human fetus at the recommended therapeutic doses are unknown; for this reason, participants must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation
- Participants must have the ability to understand and sign a consent form indicating the investigational nature of the treatment and its potential risks
Who cannot join
- Participants may not have received any prior therapy for prostate cancer including: chemotherapy, hormonal therapy, brachytherapy, or external radiation
- Participants may not be receiving concurrent systemic therapy for other cancers
- Participants may not be receiving any other investigational agents
- Participants may not be taking the following p450 inducers and inhibitors: carbamazepine, clarithromycin, fluconazole, fosphenytoin, itraconazole, ketoconazole, phenobarbital, phenytoin, rifabutin, rifampin
- Participants who took finasteride or dutasteride within 6 months of the pre-randomization biopsy, are currently taking finasteride or dutasteride, or are planning on taking these agents during study participation
- Participants with a history of allergic reactions attributed to genistein or placebo, or compounds of similar chemical or biologic composition
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- Participants with 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
- Participants requires thyroid replacement therapy; Note: participants with a history of thyroid disease > 5 years ago, with current normal thyroid function, will be considered eligible
- Participant has current, known nephrolithiasis or a history of nephrolithiasis within the past 5 years
- Participant has any history of sarcoidosis
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
Baltimore, Maryland, 21231
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Minneapolis Veterans Medical Center
Minneapolis, Minnesota, 55417
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, 55455
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
University of Rochester
Rochester, New York, 14642
Urology San Antonio Research PA
San Antonio, Texas, 78229
About this study
Official title: Phase IIA, Randomized Placebo-Controlled Trial of Single High Dose Cholecalciferol and Daily Genistein (G-2535) Versus Placebo in Men With Early Stage Prostate Cancer Undergoing Prostatectomy
This randomized phase II trial studies cholecalciferol and genistein compared to placebo in treating patients with early stage prostate cancer. Cholecalciferol and genistein may slow the growth of cancer cells and may be an effective treatment for prostate cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine differences in prostate tissue steady state concentrations of calcitriol in participants treated with a single dose cholecalciferol (200,000 IU) and G-2535 (which provides 600 mg of genistein) and those receiving placebo.
SECONDARY OBJECTIVES:
- To determine the effect of each intervention arm and resulting prostate tissue levels of calcitriol on down-stream related biomarkers and related mechanistic pathways in blood and tissue.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive cholecalciferol orally (PO) on day 1 and genistein PO once daily (QD) on days 1-21 or 1-28. Patients then undergo prostatectomy.
ARM II: Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
- Conditions
- Prostate Adenocarcinoma, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
- Being tested
- Cholecalciferol, Genistein, Laboratory Biomarker Analysis, Pharmacological Study, Placebo
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called 9,10-Secocholesta-5,7,10(19)-trien-3-ol, Calciol, Delsterol, Vitamin D3
Given PO
GenisteinDrug
Also called 4',5, 7-Trihydroxyisoflavone, Genestein, Genisteol, Prunetol
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
Correlative studies
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (cholecalciferol, genistein) | Experimental | Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy. Receives: Drug: Cholecalciferol; Drug: Genistein; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study |
| Arm II (placebo) | Placebo comparator | Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy. Receives: Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Levels of Calcitriol Between the Placebo and Cholecalciferol/Genistein Arms
This is a measure of calcitriol in prostate tissue comparing placebo and cholecalciferol/genistein
Measured: up to Day 35
Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms
To identify the amount of Calcitriol that is found in the tissue comparing Placebo and Cholecalciferol/Genistein
Measured: up to 35 days
Secondary outcomes (13)
Levels of Calcidiol in the Participants Serum
This is measuring the amount of Calcidiol that was found in the participants blood Serum at baseline and end of study
Measured: Baseline and up to day 35
Levels of Calcitriol in Participants Serum
This is measuring the amount of Calcitriol that was found in the participants blood Serum at baseline and end of study.
Measured: baseline and Up to Day 35
PBMC CYP mRNA Expression of CYP24
This is a measure of expression of CYP24 in comparing placebo to Cholecalciferol/genistein.
Measured: Baseline and Up to Day 35
PBMC CYP mRNA Expression of CYP27B1
This is a measure of expression of CYP27B1 in comparing placebo to Cholecalciferol/genistein.
Measured: Up to Day 35
Total PSA in Serum
This is a measure of the concentration of PSA in the blood serum at baseline and at the end of study.
Measured: at Baseline and up to Day 35
Serum Calcium Levels at Baseline and Pre-Surgery
This is a measurement of calcium in the Blood serum at baseline and at the end of the study.
Measured: Baseline and Day 35
Total IGF-1 in Serum at Baseline and Pre-Surgery
This is measuring the concentration of the Biomarker IGF-1 in blood serum at Baseline and at the end of the study.
Measured: Baseline and up to Day 35
Total IGF-2 in Serum at Baseline and Pre-Surgery
This is measuring the concentration of the Biomarker IGF-2 in blood serum at Baseline and at the end of the study
Measured: Baseline and Up to Day 35
Total IGFBP-3 in Serum at Baseline and Pre-Surgery
This is measuring the concentration of the Biomarker IGFBP-3 in blood serum at Baseline and at the end of the study.
Measured: Baseline and Up to Day 35
Total PTH in Serum at Baseline and Pre-Surgery
This is measuring the concentration of the Biomarker PTH in blood serum at Baseline and at the end of the study
Measured: Baseline and Up to Day 35
Immunohistochemistry Measurements in Benign Prostate Tissue (BPT)
The Immunohistochemistry measurement for: AR (Nucleus), VDR (Cytoplasm), p21 (Nucleus), PGE2 (Cytoplasm), TUNEL Pos (Nucleus), Caspase 3 (Cytoplasm), PSMA (Cytoplasm), IGF-1 and IGF-2 (Cytoplasm), Akt (Nucleus and Cytoplasm), and pAkt (nucleus and Cytoplasm)
This is to serve as normalized control data to determine expression of protein.
The normalized optical densities were measured as optical density per unit area by densitometric scanning using Vectra imaging system (Perkin Elmer).
This Optical Density is based on fluorescence.
Measured: Up to Day 35
Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA)
The Immunohistochemistry measurement for: AR (Nucleus), VDR (Cytoplasm), p21 (Nucleus), PGE2 (Cytoplasm), TUNEL Pos (Nucleus), Caspase 3 (Cytoplasm), PSMA (Cytoplasm), IGF-1 and IGF-2 (Cytoplasm), Akt (Nucleus and Cytoplasm), and pAkt (nucleus and Cytoplasm)
This is to serve as normalized case data to determine expression of protein.
The normalized optical densities were measured as optical density per unit area by densitometric scanning using Vectra imaging system (Perkin Elmer).
This Optical Density is based on fluorescence.
Measured: Up to day Day 35
Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)
Measured: up to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startDec 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David Jarrard, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325311
- Sponsor's protocol ID
- NCI-2013-00451
- Other IDs
- NCI-2013-00451, UWI09-14-01, CDR0000698228, CO-10805, CO 10805, UWI09-14-01, N01CN35153, P30CA014520
- Status last verified
- Jun 2016
- First submitted
- 23 Mar 2011
- Last updated
- 3 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIA, Randomized Placebo-Controlled Trial of Single High Dose Cholecalciferol and Daily Genistein (G-2535) Versus Placebo in Men With Early Stage Prostate Cancer Undergoing Prostatectomy
- ClinicalTrials.gov ID
- NCT01325311
- Acronym / sponsor ID
- NCI-2013-00451
- Conditions
- Prostate Adenocarcinoma, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Posted 3 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II trial studies cholecalciferol and genistein compared to placebo in treating patients with early stage prostate cancer. Cholecalciferol and genistein may slow the growth of cancer cells and may be an effective treatment for prostate cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine differences in prostate tissue steady state concentrations of calcitriol in participants treated with a single dose cholecalciferol (200,000 IU) and G-2535 (which provides 600 mg of genistein) and those receiving placebo.
SECONDARY OBJECTIVES:
- To determine the effect of each intervention arm and resulting prostate tissue levels of calcitriol on down-stream related biomarkers and related mechanistic pathways in blood and tissue.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive cholecalciferol orally (PO) on day 1 and genistein PO once daily (QD) on days 1-21 or 1-28. Patients then undergo prostatectomy.
ARM II: Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (cholecalciferol, genistein) | Experimental | Drug: Cholecalciferol, Drug: Genistein, Other: Laboratory Biomarker Analysis, Other: Pharmacological StudyPatients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy. |
| Arm II (placebo) | Placebo comparator | Other: Laboratory Biomarker Analysis, Other: Pharmacological Study, Other: PlaceboPatients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Participants must have microscopic confirmation of adenocarcinoma of the prostate within three months of randomization; clinical stage T1 and T2 a, b, or c are allowed
- Participants' prostate cancer must be confined to the prostate (in the clinical judgment of the treating physician)
- Participants must be candidates for prostatectomy
- Participants must have Eastern Cooperative Oncology Group (ECOG) performance status =<1 (Karnofsky >= 70%)
- White blood cell (WBC) within normal limits
Key exclusion criteria (10 listed)
- Participants may not have received any prior therapy for prostate cancer including: chemotherapy, hormonal therapy, brachytherapy, or external radiation
- Participants may not be receiving concurrent systemic therapy for other cancers
- Participants may not be receiving any other investigational agents
- Participants may not be taking the following p450 inducers and inhibitors: carbamazepine, clarithromycin, fluconazole, fosphenytoin, itraconazole, ketoconazole, phenobarbital, phenytoin, rifabutin, rifampin
- Participants who took finasteride or dutasteride within 6 months of the pre-randomization biopsy, are currently taking finasteride or dutasteride, or are planning on taking these agents during study participation
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 |
|---|---|---|
| CholecalciferolAlso: 9,10-Secocholesta-5,7,10(19)-trien-3-ol, Calciol, Delsterol, Vitamin D3Given PO | Drug | Arm I (cholecalciferol, genistein) |
| GenisteinAlso: 4',5, 7-Trihydroxyisoflavone, Genestein, Genisteol, PrunetolGiven PO | Drug | Arm I (cholecalciferol, genistein) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (cholecalciferol, genistein), Arm II (placebo) |
| Pharmacological StudyCorrelative studies | Other | Arm I (cholecalciferol, genistein), Arm II (placebo) |
| PlaceboAlso: placebo therapy, PLCB, sham therapyGiven PO | Other | Arm II (placebo) |
Primary outcome
Tissue Levels of Calcitriol Between the Placebo and Cholecalciferol/Genistein Arms
Time frame: up to Day 35
This is a measure of calcitriol in prostate tissue comparing placebo and cholecalciferol/genistein
Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms
Time frame: up to 35 days
To identify the amount of Calcitriol that is found in the tissue comparing Placebo and Cholecalciferol/Genistein
13 secondary outcomes
Levels of Calcidiol in the Participants Serum
Time frame: Baseline and up to day 35
Levels of Calcitriol in Participants Serum
Time frame: baseline and Up to Day 35
PBMC CYP mRNA Expression of CYP24
Time frame: Baseline and Up to Day 35
PBMC CYP mRNA Expression of CYP27B1
Time frame: Up to Day 35
Total PSA in Serum
Time frame: at Baseline and up to Day 35
Serum Calcium Levels at Baseline and Pre-Surgery
Time frame: Baseline and Day 35
Total IGF-1 in Serum at Baseline and Pre-Surgery
Time frame: Baseline and up to Day 35
Total IGF-2 in Serum at Baseline and Pre-Surgery
Time frame: Baseline and Up to Day 35
Total IGFBP-3 in Serum at Baseline and Pre-Surgery
Time frame: Baseline and Up to Day 35
Total PTH in Serum at Baseline and Pre-Surgery
Time frame: Baseline and Up to Day 35
Immunohistochemistry Measurements in Benign Prostate Tissue (BPT)
Time frame: Up to Day 35
Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA)
Time frame: Up to day Day 35
Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)
Time frame: up to Day 35
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Jarrard principal investigator
University of Wisconsin, Madison
11 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 Cholecalciferol, Genistein and Laboratory Biomarker Analysis in people with Prostate Adenocarcinoma and Stage I Prostate Cancer, run by National Cancer Institute (NCI) at 11 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 17 inclusion and 10 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 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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. 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?
Yes. Results are posted in the registry (first posted 3 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tissue Levels of Calcitriol Between the Placebo and Cholecalciferol/Genistein Arms (time frame: up to Day 35). The study lists 2 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 3 Aug 2016.