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A Trial Of COX-2 Inhibitors In PSA Recurrence After Definitive Radiation Or Radical Prostatectomy For Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Trial Of COX-2 Inhibitors In PSA Recurrence After Definitive Radiation Or Radical Prostatectomy For Prostate Cancer


OBJECTIVES:

- Determine the effect of celecoxib on prostate-specific antigen (PSA) levels in patients
with prostate cancer in biochemical relapse after prior definitive radiotherapy or
radical prostatectomy.

- Compare the PSA doubling times in patients treated with this drug vs historical
controls.

- Compare the PSA doubling times in patients treated with this drug vs pretreatment PSA
values.

- Determine the time to clinical recurrence in patients treated with this drug.

OUTLINE: Patients receive oral celecoxib twice daily. Treatment continues for 5 years in the
absence of disease progression. Patients may continue treatment beyond 5 years at the
discretion of the treating physician.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of clinically localized adenocarcinoma of the prostate

- T1 or T2 disease

- Received prior primary treatment with definitive radiotherapy (at least 5,500 cGy) OR
radical prostatectomy

- Biochemical relapse within 5 years after prior primary therapy, defined as 1 of the
following:

- Detectable and rising prostate-specific antigen (PSA) after surgery (at least 2
values above the residual cancer detection limit of the assay)

- PSA at least 2 values above 1 ng/mL OR at least 3 rising values at any level
after radiotherapy

- PSA no greater than 10 ng/mL

PATIENT CHARACTERISTICS:

Age

- Not specified

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- ALT no greater than 2.5 times upper limit of normal

Renal

- Creatinine normal

Other

- No allergy to cyclooxygenase-2 inhibitors, aspirin, nonsteroidal anti-inflammatory
drugs, or sulfa drugs

- No untreated peptic ulcer disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- More than 6 months since prior adjuvant or neoadjuvant hormonal therapy

- Duration of prior adjuvant or neoadjuvant hormonal therapy must have been no
more than 6 months

Radiotherapy

- See Disease Characteristics

- Prior salvage radiotherapy after prostatectomy allowed

Surgery

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Effect of COX-2 inhibitors on PSA level

Outcome Description:

To study the effect of COX-2 inhibitors on PSA level in patients who have only biochemical relapse after definitive radiation therapy or surgery for prostate cancer. In particular, to study the effect of celecoxib on PSA levels and PSA doubling times as compared to 1) historical controls (known and well-described median PSA doubling times of 9 months), and 2) pre-treatment PSA values and doubling times.

Outcome Time Frame:

9 months

Safety Issue:

No

Principal Investigator

Raj S. Pruthi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

LCCC 0109

NCT ID:

NCT00073970

Start Date:

April 2003

Completion Date:

January 2006

Related Keywords:

  • Prostate Cancer
  • recurrent prostate cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • adenocarcinoma of the prostate
  • Prostatic Neoplasms

Name

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570