Adenocarcinoma of the ProstatePhase 2NCT02840162
Pre-Prostatectomy Celecoxib or Placebo
A Phase 2 study testing Celecoxib in people with Adenocarcinoma of the Prostate and Prostate Cancer, run by OHSU Knight Cancer Institute at 2 sites in United States.
Trial summary
This study will seek to determine if the downstream effects of cyclooxygenase-2 (COX-2) inhibition suggested by preclinical systems occur in human prostate cancer. To answer this question, men who have chosen prostatectomy will be randomly assigned to preoperative treatment with celecoxib or placebo for four weeks. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate, Prostate Cancer
- What is being tested?
- Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2001to May 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Histopathologically or cytologically proven adenocarcinoma of the prostate and planned prostatectomy
- Age >= 18
- Performance status (ECOG <= 2)
- Hemoglobin > 10 g/dL (within 4 weeks)
- Creatinine <= 1.5 mg/dL
- Signed informed patient consent
Who cannot join
- Other preoperative or prior treatment directed at prostate cancer
- Significant active medical illness which in the opinion of the investigator would preclude protocol treatment
- Use of non-steroidal anti-inflammatory agents within seven days of celecoxib treatment
- Hypersensitivity to celecoxib
- A history of asthma, urticaria, or anaphylaxis precipitated by an NSAID
- History of significant upper gastrointestinal bleeding or active peptic ulcer disease
- Current treatment with anticoagulants
- Allergy to sulfonamide
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Portland VA Medical Center
Portland, Oregon, 97207
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Randomized Study of Pre-Prostatectomy Celecoxib or Placebo
This study will seek to determine if the downstream effects of cyclooxygenase-2 (COX-2) inhibition suggested by preclinical systems occur in human prostate cancer. To answer this question, men who have chosen prostatectomy will be randomly assigned to preoperative treatment with celecoxib or placebo for four weeks. Carefully collected tumor, premalignant, and benign prostate tissue will then be examined for apoptosis, androgen receptor and prostaglandin E2 levels. Tumor COX-2 expression will be correlated with observed treatment effects. The data generated by this study will serve as a foundation for the development of COX-2 targeted therapies for prostate cancer, will provide preliminary evidence for larger scale clinical trials aimed at treatment and prevention of prostate cancer, and will validate current preclinical models used to study COX-2 in prostate cancer.
Read the detailed description
PRIMARY OBJECTIVE
- To determine if COX-2 inhibition with celecoxib significantly increases apoptosis in human adenocarcinoma of the prostate.
SECONDARY OBJECTIVES
- To determine if COX-2 inhibition with celecoxib reduces levels of Prostaglandin E2 and androgen receptor in fresh tumor tissue collected at prostatectomy
II. To collect pre- and postoperative serum Prostate Specific Antigen (PSA) for exploratory analyses
III. To determine the effect of celecoxib on adverse effects, perioperative surgical complications and post surgery analgesic use
- Conditions
- Adenocarcinoma of the Prostate, Prostate Cancer
- Being tested
- Celecoxib, Placebo
- Keywords
- prostate cancer, NSAIDs, chemoprevention, celecoxib, COX-2 inhibitors
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called Celebrex, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl], Benzenesulfonamide
Selective inhibition of COX-2 without significant cyclooxygenase-1 (COX-1) inhibition
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib | Active comparator | Treated patients will receive 4 weeks of celecoxib at 400 mg twice daily by mouth Receives: Drug: Celecoxib |
| Placebo | Placebo comparator | Control patients will receive a suitable placebo for 4 weeks, twice daily by mouth Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apoptosis Index, defined as the percent positive staining cells
Percent positively staining cells with a minimum of 1000 total cells counted. Descriptive statistics will be conducted. The apoptotic index will be reported with 95% confidence intervals.
Measured: approximately 4 weeks of treatment
Secondary outcomes (5)
Prostaglandin and Androgen Receptor Levels
Descriptive statistical analysis will be conducted. The estimates will be reported with 95% confidence intervals.
Measured: approximately 4 weeks of treatment
Percent Change in Median PSA Values, pre- and postoperatively
Pre- and postoperative PSA will be collected. Descriptive statistics will be conducted, comparing preoperative PSA level to postoperative level.
Measured: approximately 4 weeks of treatment
Perioperative Analgesic Use, using morphine equivalents
Descriptive statistical analysis will be conducted. The estimate will be calculated using morphine equivalents dividend by length of hospital stay and reported with 95% confidence intervals.
Measured: Prostatectomy to discharge from hospital, no more than 30 days post prostatectomy
Surgical Complications, defined as incidence of adverse events determined to be related to surgery graded by NCI CTCAE version 2.0
Intraoperative and post surgical complications will be collected and reported.
Measured: Intraoperatively to 30 days postoperatively
Incidence of Adverse Events, graded by NCI CTCAE version 2.0
Descriptive statistical analysis will be conducted
Measured: From start of treatment to 30 days post prostatectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startMay 2001
- Primary completionJan 2005
- Study completionMay 2011
Why it stopped: Drug safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Tom Beer, OHSU Knight Cancer Institute
- Investigators
- Tomasz M Beer, MD, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840162
- Sponsor's protocol ID
- IRB00001004
- Other IDs
- HOR-01019-L
- Status last verified
- Apr 2017
- First submitted
- 15 Jul 2016
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Pre-Prostatectomy Celecoxib or Placebo
- ClinicalTrials.gov ID
- NCT02840162
- Acronym / sponsor ID
- IRB00001004
- Conditions
- Adenocarcinoma of the Prostate, Prostate Cancer
- Keywords
- prostate cancer, NSAIDs, chemoprevention, celecoxib, COX-2 inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drug safety concerns
- Enrolment
- 34 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- May 2001
- Primary completion
- Jan 2005 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will seek to determine if the downstream effects of cyclooxygenase-2 (COX-2) inhibition suggested by preclinical systems occur in human prostate cancer. To answer this question, men who have chosen prostatectomy will be randomly assigned to preoperative treatment with celecoxib or placebo for four weeks. Carefully collected tumor, premalignant, and benign prostate tissue will then be examined for apoptosis, androgen receptor and prostaglandin E2 levels. Tumor COX-2 expression will be correlated with observed treatment effects. The data generated by this study will serve as a foundation for the development of COX-2 targeted therapies for prostate cancer, will provide preliminary evidence for larger scale clinical trials aimed at treatment and prevention of prostate cancer, and will validate current preclinical models used to study COX-2 in prostate cancer.
Detailed description
PRIMARY OBJECTIVE
- To determine if COX-2 inhibition with celecoxib significantly increases apoptosis in human adenocarcinoma of the prostate.
SECONDARY OBJECTIVES
- To determine if COX-2 inhibition with celecoxib reduces levels of Prostaglandin E2 and androgen receptor in fresh tumor tissue collected at prostatectomy
II. To collect pre- and postoperative serum Prostate Specific Antigen (PSA) for exploratory analyses
III. To determine the effect of celecoxib on adverse effects, perioperative surgical complications and post surgery analgesic use
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celecoxib | Active comparator | Drug: CelecoxibTreated patients will receive 4 weeks of celecoxib at 400 mg twice daily by mouth |
| Placebo | Placebo comparator | Drug: PlaceboControl patients will receive a suitable placebo for 4 weeks, twice daily by mouth |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histopathologically or cytologically proven adenocarcinoma of the prostate and planned prostatectomy
- Age >= 18
- Performance status (ECOG <= 2)
- Hemoglobin > 10 g/dL (within 4 weeks)
- Creatinine <= 1.5 mg/dL
Key exclusion criteria (8 listed)
- Other preoperative or prior treatment directed at prostate cancer
- Significant active medical illness which in the opinion of the investigator would preclude protocol treatment
- Use of non-steroidal anti-inflammatory agents within seven days of celecoxib treatment
- Hypersensitivity to celecoxib
- A history of asthma, urticaria, or anaphylaxis precipitated by an NSAID
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 |
|---|---|---|
| CelecoxibAlso: Celebrex, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl], BenzenesulfonamideSelective inhibition of COX-2 without significant cyclooxygenase-1 (COX-1) inhibition | Drug | Celecoxib |
| Placebo | Drug | Placebo |
Primary outcome
Apoptosis Index, defined as the percent positive staining cells
Time frame: approximately 4 weeks of treatment
Percent positively staining cells with a minimum of 1000 total cells counted. Descriptive statistics will be conducted. The apoptotic index will be reported with 95% confidence intervals.
5 secondary outcomes
Prostaglandin and Androgen Receptor Levels
Time frame: approximately 4 weeks of treatment
Percent Change in Median PSA Values, pre- and postoperatively
Time frame: approximately 4 weeks of treatment
Perioperative Analgesic Use, using morphine equivalents
Time frame: Prostatectomy to discharge from hospital, no more than 30 days post prostatectomy
Surgical Complications, defined as incidence of adverse events determined to be related to surgery graded by NCI CTCAE version 2.0
Time frame: Intraoperatively to 30 days postoperatively
Incidence of Adverse Events, graded by NCI CTCAE version 2.0
Time frame: From start of treatment to 30 days post prostatectomy
Results and safety
The study was stopped early (reason given: Drug safety concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
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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.
Tomasz M Beer, MD principal investigator
OHSU Knight Cancer Institute
2 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 Celecoxib in people with Adenocarcinoma of the Prostate and Prostate Cancer, run by OHSU Knight Cancer Institute at 2 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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study was stopped early (reason given: Drug safety concerns). Results are not available in the source record.
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?
Apoptosis Index, defined as the percent positive staining cells (time frame: approximately 4 weeks of treatment). 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 28 Apr 2017.