A Randomized, Double Blind, Placebo-Controlled Trial of Celecoxib Versus Placebo in Men With Prostate Cancer With Rising PSA Following Prostatectomy or Radiation Therapy
This study is designed as a randomized, double blind, placebo-controlled study. These are
all scientific research methods used to protect the study from personal bias or prejudice.
Patients who participate in this study will be randomly assigned initially to take either
celecoxib (the study drug) or placebo (an inactive substance that looks like the study
drug). Placebos are used to help determine if the results of a study (good or bad) result
from chance or from treatment with the study drug. Patients will have a fifty-fifty chance
of initial treatment with the study drug. Neither the patient nor the patient's doctor will
know whether he/she is initially receiving the study drug or placebo. Participants who are
assigned to initially take placebo may have the opportunity to be treated with celecoxib
later in the study.
If patients are found to be eligible for this study and they agree to participate, they will
be randomized to either receive celecoxib or placebo to be taken by mouth (as a pill) twice
a day, every day for as long as they are in the study. Patients will be given a pill diary
to keep track of their medications. While in this study, they will be asked not to take any
non-steroidal anti-inflammatory drugs, which includes over-the-counter ibuprofen and many
other available drugs. In addition, they will be asked not to take any other selective
COX-2 inhibitors (the class of drug that celecoxib is).
While in this study, patients will have evaluations (physical exam and blood) to determine
their response to their assigned regimen and to monitor side effects.
Once a month the following will be performed:
- Review of any side effects
- Physical Exam
- Routine blood tests (PSA level, kidney function). About one tablespoon of blood will be
taken at each visit.
Every other month starting with month 2:
In addition to the above evaluations, on alternating months starting with month 2,
additional routine blood tests (liver function, complete blood count) will be done. This
will require an additional tablespoon of blood to be taken at these visits.
Additional blood for research-related testing (about 2-3 tablespoons) will also be drawn
during these visits.
Participation in this study will be determined by how well patients tolerate the assigned
regimen and by how their disease responds. Patients will continue taking their assigned
regimen for 6 months as long as it is felt that their disease is stable (based on their PSA
levels) and they are tolerating the treatment. After 6 months or earlier, if the disease
progresses, the treatment code will be broken. If patients were on celecoxib, they will be
taken off study. The patient's doctor will discuss other available treatment options with
him/her at that time, including continuing celecoxib "off study". If patients were on
placebo, they will then have the option to begin taking celecoxib. If patients start
celecoxib treatment, they will be treated in this study with celecoxib for 6 months or until
their disease progresses. After 6 months on celecoxib or sooner, if their disease
progresses, they will be taken off study. The patient's doctor will discuss available
treatment options with him/her at that time, including continuing celecoxib "off study".
Patients who are taken "off study" will be monitored monthly for patient safety reasons
throughout the duration of time that they are receiving celecoxib at the dose level used for
this study (400mg twice a day).
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
To evaluate the biologic activity of celecoxib by comparing the proportion of men with a post-treatment PSA doubling time (PSADT) greater than or equal to 200% pre-treatment PSADT in the celecoxib-treated group compared to the placebo-treated group
Philip W. Kantoff, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|MD Anderson Cancer Center||Houston, Texas 77030-4096|
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Hartford Hospital||Hartford, Connecticut 06102-5037|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Faulkner Hospital||Jamaica Plain, Massachusetts 02130|
|Lowell General Hospital||Lowell, Massachusetts 01854|
|Emerson Hospital||Concord, Massachusetts 01742|