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Adenocarcinoma of the ProstatePhase 2NCT00087139

Ixabepilone in Treating Patients With Metastatic Prostate Cancer

A Phase 2 study testing ixabepilone in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 162 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well ixabepilone works in treating patients with metastatic prostate cancer that has not responded to previous hormone therapy. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
ixabepilone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
162 sitesUnited States
Study dates
Sep 2004to Feb 2011
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

  • Histologically confirmed adenocarcinoma of the prostate
  • Metastatic disease
  • Evidence of disease progression (e.g., new lesions on bone scan or new/enlarging lesions on CT scan) OR rising prostate-specific antigen (PSA) within the past 4 weeks
  • Radiologic evidence of hydronephrosis alone is not considered evidence of metastatic disease (e.g., increasing PSA)
  • Patients with bone metastases only (i.e., lacking soft tissue disease) must have a PSA level >= 10 ng/mL within the past week
  • Patients with stable disease and rising PSA must show 2 consecutive rises in PSA measurements taken at least 2 weeks apart
Show all 47Show fewer
  • Most recent PSA level must be obtained within the past 4 weeks
  • Disease progression after prior anti-androgen withdrawal must be confirmed by a rising PSA after the 4-6 week washout period (e.g., PSA level higher than the last PSA obtained while on anti-androgen therapy)
  • Failed prior bilateral orchiectomy or other primary hormonal therapy
  • Patients who have not undergone bilateral orchiectomy must continue on luteinizing hormone-releasing hormone (LHRH) agonist therapy (e.g., leuprolide or goserelin) or LHRH antagonist (e.g., abarelix) during study treatment AND must have a serum testosterone level =< 50 ng/dL within the past 4 weeks to confirm androgen suppression
  • ECOG 0-2
  • Granulocyte count >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • WBC >= 4,000/mm^3
  • SGPT =< 2 times upper limit of normal
  • Bilirubin =< 1.5 mg/dL
  • INR normal
  • Creatinine =< 1.5 mg/dL
  • Creatinine clearance >= 50 mL/min
  • No New York Heart Association class III-IV heart disease
  • No myocardial infarction within the past 6 months
  • No active angina pectoris
  • No evidence of ventricular dysrhythmias or other unstable arrhythmia
  • Rate-controlled atrial fibrillation allowed provided the patient is asymptomatic
  • No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer
  • No serious medical illness or active infection that would preclude study participation
  • No concurrent prophylactic filgrastim (G-CSF)
  • No more than 2 prior cytotoxic chemotherapy regimens for hormone-refractory disease
  • At least 4 weeks since prior chemotherapy with a taxane-based regimen, mixantrone, or another cytotoxic chemotherapy regimen provided there is evidence of progressive disease
  • At least 4 weeks since prior flutamide AND continued evidence of progressive disease
  • At least 6 weeks since prior bicalutamide or nilutamide AND continued evidence of progressive disease
  • At least 4 weeks since prior estrogen or estrogen-like agents (e.g., PC-SPES, saw palmetto, or other herbal products which may contain phytoestrogens)
  • At least 4 weeks since prior hormonal therapy, including megestrol, finasteride, ketoconazole, or systemic corticosteroids
  • No concurrent estrogen or estrogen-like agents (e.g., PC-SPES, saw palmetto, or other herbal products which may contain phytoestrogens)
  • More than 4 weeks since prior radiotherapy
  • No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium
  • No other prior radioisotope
  • No concurrent radiotherapy for pain control
  • No more than 1 prior experimental (non-cytotoxic) therapy AND evidence of progressive disease
  • At least 4 weeks since prior experimental therapy
  • Concurrent bisphosphonates (e.g., pamidronate or zoledronate) allowed provided treatment was initiated at least 4 weeks ago and there is evidence of progressive disease
  • No other concurrent investigational agents
  • No concurrent therapeutic warfarin
  • Concurrent prophylactic or therapeutic doses of low molecular weight heparin allowed provided criterion for INR is met
  • No carcinomatous meningitis or brain metastases
  • Fertile patients must use effective contraception
  • No peripheral neuropathy > grade 1

Who cannot join

None listed.

Trial locations and contacts

162 sites in 1 country.

162 sites in 1 country

United States162 sites

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18105

  • McFarland Clinic PC-William R Bliss Cancer Center

    Ames, Iowa, 50010

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • Michigan Cancer Research Consortium Community Clinical Oncology Program

    Ann Arbor, Michigan, 48106

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

  • Constantinou, Costas L MD (UIA Investigator)

    Bettendorf, Iowa, 52722

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Eastern Cooperative Oncology Group

    Boston, Massachusetts, 02215

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Ocean Medical Center

    Brick, New Jersey, 08724

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Graham Hospital Association

    Canton, Illinois, 61520

  • Mercy Medical Center

    Canton, Ohio, 44708

  • Saint Anthony Regional Hospital

    Carroll, Iowa, 51401

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Saint Luke's Hospital

    Cedar Rapids, Iowa, 52402

  • Cedar Rapids Oncology Association

    Cedar Rapids, Iowa, 52403

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

  • Oakwood Hospital

    Dearborn, Michigan, 48124

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Exempla Saint Joseph Hospital

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • Colorado Cancer Research Program CCOP

    Denver, Colorado, 80224-2522

  • Mercy Capitol

    Des Moines, Iowa, 50307

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa Oncology Research Association CCOP

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Essentia Health Duluth Clinic CCOP

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Sacred Heart Hospital

    Eau Claire, Wisconsin, 54701

  • Advocate Sherman Hospital

    Elgin, Illinois, 60123

  • Alexian Brothers Medical and Cancer Center

    Elk Grove Village, Illinois, 60007

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Green Bay Oncology - Escanaba

    Escanaba, Michigan, 49431

  • Eureka Hospital

    Eureka, Illinois, 61530

  • Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • Hurley Medical Center

    Flint, Michigan, 48502

  • Genesys Regional Medical Center-West Flint Campus

    Flint, Michigan, 48532

  • Fremont Area Medical Center

    Fremont, Nebraska, 68025

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • Illinois CancerCare Galesburg

    Galesburg, Illinois, 61401

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81502

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Cancer Institute of New Jersey At Hamilton

    Hamilton, New Jersey, 08690

  • Mason District Hospital

    Havana, Illinois, 62644

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Hopedale Medical Complex - Hospital

    Hopedale, Illinois, 61747

  • Green Bay Oncology - Iron Mountain

    Iron Mountain, Michigan, 49801

  • Allegiance Health

    Jackson, Michigan, 49201

  • Edna Williams Cancer Center at the Baptist Cancer Institute

    Jacksonville, Florida, 32207

  • UW Cancer Center Johnson Creek

    Johnson Creek, Wisconsin, 53038

  • Joliet Oncology-Hematology Associates Limited

    Joliet, Illinois, 60435

  • Kalamazoo Center for Medical Studies

    Kalamazoo, Michigan, 49008

  • Kewanee Hospital

    Kewanee, Illinois, 61443

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • Gundersen Lutheran

    La Crosse, Wisconsin, 54601

  • Indiana University Health La Porte Hospital

    La Porte, Indiana, 46350

  • Lakeland Regional Cancer Center

    Lakeland, Florida, 33805

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Lewistown Hospital

    Lewistown, Pennsylvania, 17044

  • Bryan LGH Medical Center West

    Lincoln, Nebraska, 68502

  • Bryan LGH Medical Center East

    Lincoln, Nebraska, 68506

  • Saint Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

  • Meeker County Memorial Hospital

    Litchfield, Minnesota, 55355

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Mcdonough District Hospital

    Macomb, Illinois, 61455

  • UW Health Oncology - 1 South Park

    Madison, Wisconsin, 53715

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Franciscan Saint Anthony Health-Michigan City

    Michigan City, Indiana, 46360

  • Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55407

  • Saint Joseph Regional Medical Center-Mishawaka

    Mishawaka, Indiana, 46545-1470

  • Community Memorial Hospital

    Missouri Valley, Iowa, 51555

  • Garneau, Stewart C MD (UIA Investigator)

    Moline, Illinois, 61265

  • Porubcin, Michael MD (UIA Investigator)

    Moline, Illinois, 61265

  • Sharis, Christine M MD (UIA Investigator)

    Moline, Illinois, 61265

  • Stoffel, Thomas J MD (UIA Investigator)

    Moline, Illinois, 61265

  • Vigliotti, Antonio, P.G. M.D. (UIA Investigator)

    Moline, Illinois, 61265

  • Mountainside Hospital

    Montclair, New Jersey, 07042

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County

    Mount Holly, New Jersey, 08060

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Bromenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center Foundation

    Normal, Illinois, 61761

  • Green Bay Oncology - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • Burgess Memorial Hospital

    Onawa, Iowa, 51040

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Ottawa Regional Hospital and Healthcare Center

    Ottawa, Illinois, 61350

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

  • Midlands Community Hospital

    Papillion, Nebraska, 68046

  • Pekin Cancer Treatment Center

    Pekin, Illinois, 61554

  • Pekin Hospital

    Pekin, Illinois, 61554

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61603

  • Proctor Hospital

    Peoria, Illinois, 61614

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Illinois Oncology Research Association CCOP

    Peoria, Illinois, 61615

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois Valley Hospital

    Peru, Illinois, 61354

  • Saint Joseph Regional Medical Center - Mishawaka

    Plymouth, Indiana, 46544

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Saint Joseph Mercy Port Huron

    Port Huron, Michigan, 48060

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Saint Mary Corwin Medical Center

    Pueblo, Colorado, 81004

  • Marshfield Clinic-Rice Lake Center

    Rice Lake, Wisconsin, 54868

  • Saint Mary's of Michigan

    Saginaw, Michigan, 48601

  • Lakeland Hospital

    Saint Joseph, Michigan, 49085

  • Saint Joseph's Hospital - Healtheast

    Saint Paul, Minnesota, 55102

  • Nanticoke Memorial Hospital

    Seaford, Delaware, 19973

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101-1733

  • Siouxland Hematology Oncology Associates

    Sioux City, Iowa, 51101

  • Mercy Medical Center-Sioux City

    Sioux City, Iowa, 51104

  • Saint Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Sanford Cancer Center-Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Medical X-Ray Center

    Sioux Falls, South Dakota, 57105

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • South Bend Clinic

    South Bend, Indiana, 46617

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46628

  • Saint Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • Mount Nittany Medical Center

    State College, Pennsylvania, 16803

  • Green Bay Oncology - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • Overlook Hospital

    Summit, New Jersey, 07902

  • Morton Hospital and Medical Center

    Taunton, Massachusetts, 02780

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Montefiore Medical Center-Wakefield Campus

    The Bronx, New York, 10466

  • Montefiore Medical Center

    The Bronx, New York, 10467-2490

  • North Suburban Medical Center

    Thornton, Colorado, 80229

  • Carle Clinic-Urbana Main

    Urbana, Illinois, 61801

  • Virtua West Jersey Hospital Voorhees

    Voorhees Township, New Jersey, 08043

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • Marshfield Clinic - Weston Center

    Weston, Wisconsin, 54476

  • Exempla Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • Saint Francis Hospital - Wilmington

    Wilmington, Delaware, 19805

  • Marshfield Clinic - Wisconsin Rapids Center

    Wisconsin Rapids, Wisconsin, 54494

  • Woodwinds Health Campus

    Woodbury, Minnesota, 55125

  • Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

  • Mainline Health CCOP

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

Official title: Phase II Study of a Weekly Schedule of BMS-247550 for Patients With Hormone Refractory Prostate Cancer

Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well ixabepilone works in treating patients with metastatic prostate cancer that has not responded to previous hormone therapy.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the effect on percent with a 50% decrease in PSA response in patients with metastatic prostate cancer who have progressed on androgen ablation therapy and are classified into 1 of 3 separate categories:
  2. Never received prior chemotherapy/cytotoxic therapy
  3. Received prior taxane-based regimen
  4. Received 2 prior cytotoxic chemotherapy regimens (including, but not limited to, prior taxane and anthracyclines)

SECONDARY OBJECTIVES:

  1. Determine measurable disease response in patients with measurable disease treated with this drug and overall response rate.

II. Determine the toxic effects of this drug in these patients. III. Determine the duration of PSA and measurable disease response in patients treated with this drug.

IV. Determine the expression of p53, multidrug resistance protein, and Bcl-2 by immunohistochemistry in the primary tumors of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (none vs 1 prior taxane-containing regimen vs 2 prior cytotoxic regimens).

Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Being tested
ixabepilone
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • ixabepiloneDrug

    Also called BMS-247550, epothilone B lactam, Ixempra

    Given IV

Study groups in NCT00087139
Study groupRoleWhat they receive
Arm IExperimentalPatients are stratified according to prior chemotherapy (none vs 1 prior taxane-containing regimen vs 2 prior cytotoxic regimens). Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: ixabepilone

What is being measured

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

  1. Proportion of Patients With PSA Response

    PSA response is defined as a decline from baseline value by >=50%, or normalization of PSA (PSA < 0.2 ng/lm), confirmed by a second measurement >= 4 weeks later. The proportion of patients with PSA response was reported separately for 3 strata. Additional patients accrued to this study were not included in this analysis.

    Measured: Every 4 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry

Secondary outcomes (3)

  1. Proportion of Patients With Measurable Disease Response (Best Overall Response)

    Only patients with measurable disease were included in this analysis. The proportion of patients with measurable disease response (based on RECIST: Response Evaluation Criteria in Solid Tumors) was reported separately for 3 strata.

    Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.

    Objective response = CR + PR

    Measured: Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry

  2. Duration of PSA Response

    Duration of PSA response was defined as the time from the date of onset of PSA response until the date the criteria were met for PSA progression. Only patients with a PSA response were included in this analysis. The results were reported separately for 3 strata.

    Measured: Every 4 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry

  3. Duration of Measurable Disease Response

    Duration of measurable disease response was defined as the time from the date when measurement criteria were met for complete or partial response, whichever status was recorded first, until the first date that recurrent or progressive disease was objectively documented based on RECIST (Response Evaluation Criteria in Solid Tumors). Only patients with measurable disease response were included in this analysis.

    Measured: Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry

Timeline

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

  1. First posted12 Jul 2004 (estimated)
  2. Study startSep 2004
  3. Primary completionApr 2009
  4. Study completionFeb 2011

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00087139
Sponsor's protocol ID
NCI-2009-00548
Other IDs
NCI-2009-00548, CDR0000372946, E3803, E3803, E3803, U10CA021115
Status last verified
Apr 2013
First submitted
8 Jul 2004
Last updated
9 May 2014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ixabepilone in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 162 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 47 inclusion and 0 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 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 162 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?

Yes. Results are posted in the registry (first posted 27 Dec 2012). 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?

Proportion of Patients With PSA Response (time frame: Every 4 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry). 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 NCT00087139.

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 May 2014.

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