NCT00022399

Brief Summary

RATIONALE: Celecoxib may be an effective treatment for early stage prostate cancer. It is not yet known if celecoxib is more effective than no treatment before surgery for prostate cancer. PURPOSE: Randomized phase I trial to determine the effectiveness of celecoxib given before surgery to remove the prostate in treating patients who have localized prostate cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Apr 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2001

Completed
9 months until next milestone

Study Start

First participant enrolled

April 25, 2002

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2005

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

2.8 years

First QC Date

August 10, 2001

Last Update Submit

February 6, 2019

Conditions

Prostate Cancer

Keywords

stage I prostate cancerstage IIB prostate cancerstage IIA prostate canceradenocarcinoma of the prostate

Study Arms (2)

Celecoxib

EXPERIMENTAL

Participants receive celecoxib 400mg by mouth twice daily for 4 to 6 weeks prior to standard-of-care prostatectomy.

Drug: celecoxib

Placebo-control

PLACEBO COMPARATOR

Participants receive placebo for 4 to 6 weeks prior to standard-of-care prostatectomy.

Drug: Placebos

Interventions

celecoxibDRUG

400mg PO twice daily for 4-6 weeks up to 8 hours prior to prostatectomy.

Also known as: celebrex
Celecoxib
PlacebosDRUG

Placebo PO twice daily for 4-6 weeks up to 8 hours prior to prostatectomy.

Placebo-control

Eligibility Criteria

Age18 Years - 120 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed localized adenocarcinoma of the prostate with one or more of the following: * Gleason sum at least 7 * Prostate-specific antigen (PSA) at least 15 ng/mL * Clinical stage T2b or T2c (stage II) * Any combination of PSA, clinical stage, or Gleason sum with an estimated risk of capsular penetration greater than 45% * At least 3 positive core biopsies * Planned radical prostatectomy * No metastatic disease secondary to prostate cancer PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * WBC greater than 3,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 9 g/dL * No history of bleeding disorders Hepatic: * Bilirubin less than 1.5 mg/dL * AST/ALT less than 1.5 times upper limit of normal * No viral hepatitis Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 50 mL/min Other: * No history of hypersensitivity and/or adverse reactions to salicylates * No allergy to sulfa-containing medications * No other active malignancy within the past 5 years except superficial bladder cancer or nonmelanoma skin cancer * No medical or psychiatric problem that would preclude study participation * No active infection * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunologic therapy for prostate cancer Chemotherapy: * At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: * No prior androgen ablation for prostate cancer * At least 4 weeks since prior hormonal therapy and recovered * At least 30 days since prior chronic use (more than 3 times per week for more than 2 weeks) of glucocorticoids * No concurrent glucocorticoids Radiotherapy: * At least 4 weeks since prior radiotherapy to the pelvis or surrounding tissues and recovered Surgery: * See Disease Characteristics * At least 4 weeks since prior major surgery and recovered Other: * No prior investigational therapy for prostate cancer * No prior or concurrent chronic anticoagulants * No prior cyclo-oxygenase-2 inhibitor therapy (e.g., rofecoxib or celecoxib) * At least 4 weeks since prior initiation of vitamins (except multivitamin) or herbs with known effects on prostate function (PSA) * At least 30 days since prior chronic use (more than 3 times per week for more than 2 weeks) of aspirin (greater than 100 mg/day) or non-steroidal anti-inflammatory drugs (NSAIDs) * At least 24 hours since prior use and no concurrent use of any of the following: * Over-the-counter (OTC) or prescription products containing aspirin or NSAIDs; OTC products containing bismuth subsalicylate, sodium salicylate, and/or magnesium salicylate; choline salicylate; ranitidine; cimetidine; famotidine; or lansoprazole * No aspirin (100 mg/day) within 1 week prior to surgery * No concurrent addition of vitamins or herbal supplements

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Related Publications (1)

  • Antonarakis ES, Heath EI, Walczak JR, Nelson WG, Fedor H, De Marzo AM, Zahurak ML, Piantadosi S, Dannenberg AJ, Gurganus RT, Baker SD, Parnes HL, DeWeese TL, Partin AW, Carducci MA. Phase II, randomized, placebo-controlled trial of neoadjuvant celecoxib in men with clinically localized prostate cancer: evaluation of drug-specific biomarkers. J Clin Oncol. 2009 Oct 20;27(30):4986-93. doi: 10.1200/JCO.2009.21.9410. Epub 2009 Aug 31.

    PMID: 19720908RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Michael A. Carducci, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2001

First Posted

January 27, 2003

Study Start

April 25, 2002

Primary Completion

January 31, 2005

Study Completion

January 31, 2005

Last Updated

February 8, 2019

Record last verified: 2019-02

Locations

US(1)