Prostate CancerPhase 2NCT00138918
Study of OGX-011 Given Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer
A Phase 2 study testing OGX-011 in people with Prostate Cancer, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this trial is to assess the effects of combined therapy with androgen ablation and OGX-011 (an antisense to clusterin) given prior to radical prostatectomy on pathologic complete response rates in men with localized prostate cancer and high risk features. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- OGX-011
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2005to 13 May 2008
- 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
- Histologically confirmed adenocarcinoma of the prostate, previously untreated
- Males ≥ 18 years of age.
- Potential candidate for radical prostatectomy
- Any of the following (minimum of 2 positive biopsies):
- Clinical stage T3
- Serum PSA > 10 ng/ml
Show all 14Show fewer
- Gleason score 7-10
- Gleason score 6 and > 3 positive biopsies
- ECOG performance status 0-1
- WBC ≥ 3.0 x 10^9/L
- Hemoglobin ≥ 100 g/L
- Platelets ≥ 100 x 10^9/L
- PTT, INR, AST, ALT, creatinine, total bilirubin within normal limits
- Patients must sign an informed consent that complies with US Regulations (US 21 Code of Federal Regulations [CFR]) and the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP) prior to undergoing treatment.
Who cannot join
- Prior hormone, radiation, or chemotherapy for prostate cancer
- Evidence of active infection
- Patients receiving therapeutic doses of warfarin or heparin
- Severe end organ disease
- Patients who otherwise would not be candidates for radical prostatectomy because of health or tumour factors
- Patients will be excluded if they had any prior malignancy unless the prior malignancy was diagnosed and definitively treated at least five years previously and there has never been any evidence of recurrence.
- Other serious illness, psychiatric, or medical condition that would not permit the patient to be managed according to the protocol.
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Cancer Agency and Vancouver General Hospital
Vancouver, British Columbia, V5Z 1L8
About this study
Official title: A Phase II Study of OGX-011 Given Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer
The purpose of this trial is to assess the effects of combined therapy with androgen ablation and OGX-011 (an antisense to clusterin) given prior to radical prostatectomy on pathologic complete response rates in men with localized prostate cancer and high risk features.
Read the detailed description
Clusterin as an anti-apoptotic cytoprotective chaperone protein upregulated in an adaptive cell survival manner that confers resistance to various cell death triggers, including hormone-, radiation-, and chemotherapy. In pre-clinical models, inhibition of clusterin expression using the second generation antisense OGX-011 can enhance cell death following treatment with androgen ablation, radiotherapy, and chemotherapy. In phase I clinical trials, OGX-011 has been well tolerated and a biologically effective dose has been identified in humans.
Study Design
This is an open-label, non-blinded, phase II clinical, tissue pharmacokinetic and pharmacodynamic study of weekly OGX-011 and neoadjuvant hormone therapy prior to radical prostatectomy in patients with localized prostate carcinoma and high-risk features.
Study Objectives
Primary Objectives
- To assess the effects of combined neoadjuvant hormone therapy (NHT) and OGX-011 prior to radical prostatectomy on pathologic complete response rates in men with high risk localized prostate cancer.
Secondary Objectives
- To quantify changes in clusterin expression in residual prostate cancer after treatment with NHT and OGX-011.
- To measure levels of full length OGX-011 in prostate tissues after 3 months of NHT.
- To assess the safety and tolerability toxicity of 3 months of OGX-011 and NHT prior to radical prostatectomy.
- To measure evidence of OGX-011's effect on clusterin expression in patient peripheral blood mononuclear cells (PBMNC).
- To measure evidence of OGX-011's effect on patient clusterin serum levels.
- To assess the effects of combined NHT and OGX-011 on time to PSA nadir.
- To determine PSA recurrence rates after combined NHT and OGX-011.
Key Eligibility Criteria
- Histologically confirmed adenocarcinoma of the prostate, previously untreated
- Potential candidate for radical prostatectomy
- Any one of the following criteria (minimum of 2 positive biopsies):
- Clinical stage T3
- Serum PSA > 10 ng/ml
- Gleason score 7-10
- Gleason score 6 and > 3 positive biopsies
- ECOG performance status 0-1
- WBC ≥ 3.0 x 10^9/L
- Hemoglobin ≥ 100 g/L
- Platelets ≥ 100 x 10^9/L
- PTT, INR, AST, ALT, creatinine, total bilirubin within normal limits
Treatment Plan
Approximately 45 newly diagnosed, previously untreated patients with clinically localized, high-risk prostate carcinoma will be entered into this trial. These patients will receive neoadjuvant hormone therapy (buserelin 9.9 mg subcutaneously x 1 injection with flutamide 250 mg orally T.I.D. for the first 4 weeks only) for 12 weeks in combination with OGX-011 (a 2'MOE phosphorothioate clusterin antisense oligonucleotide) weekly on a 4 week cycle for 3 courses. For week one, cycle one only, OGX-011 will be given on Days 1, 3 and 5. OGX-011 is given at a dose of 640 mg by intravenous infusion over 2 hours. Radical prostatectomy will take place within 14 days of the last dose of OGX-011.
- Conditions
- Prostate Cancer
- Being tested
- OGX-011
- Keywords
- Prostate Cancer, Clusterin, Neoadjuvant, Phase II
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OGX-011Biological
See Detailed Description, Treatment Plan
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effects of combined neoadjuvant hormone therapy (NHT) and OGX-011 prior to radical prostatectomy on pathologic complete response rates in men with high risk localized prostate cancer
Measured: See Detailed Description, Treatment Plan
Secondary outcomes (7)
To quantify changes in clusterin expression in residual prostate cancer after treatment with NHT and OGX-011
Measured: See Detailed Description, Treatment Plan
To measure levels of full length OGX-011 in prostate tissues after 3 months of NHT
Measured: See Detailed Description, Treatment Plan
To assess the safety and tolerability toxicity of 3 months of OGX-011 and NHT prior to radical prostatectomy
Measured: See Detailed Description, Treatment Plan
To measure evidence of OGX-011's effect on clusterin expression in patient peripheral blood mononuclear cells (PBMNC)
Measured: See Detailed Description, Treatment Plan
To measure evidence of OGX-011's effect on patient clusterin serum levels
Measured: See Detailed Description, Treatment Plan
To assess the effects of combined NHT and OGX-011 on time to prostate specific antigen (PSA) nadir
Measured: See Detailed Description, Treatment Plan
To determine PSA recurrence rates after combined NHT and OGX-011
Measured: See Detailed Description, Treatment Plan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startJun 2005
- Primary completion13 May 2008
- Study completion13 May 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Dr. Kim Chi, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138918
- Sponsor's protocol ID
- R04-0092
- Status last verified
- Mar 2017
- First submitted
- 26 Aug 2005
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of OGX-011 Given Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT00138918
- Acronym / sponsor ID
- R04-0092
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Clusterin, Neoadjuvant, Phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Jun 2005
- Primary completion
- 13 May 2008 (actual)
- Study completion
- 13 May 2008 (actual)
- First posted
- 30 Aug 2005 (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.
The purpose of this trial is to assess the effects of combined therapy with androgen ablation and OGX-011 (an antisense to clusterin) given prior to radical prostatectomy on pathologic complete response rates in men with localized prostate cancer and high risk features.
Detailed description
Clusterin as an anti-apoptotic cytoprotective chaperone protein upregulated in an adaptive cell survival manner that confers resistance to various cell death triggers, including hormone-, radiation-, and chemotherapy. In pre-clinical models, inhibition of clusterin expression using the second generation antisense OGX-011 can enhance cell death following treatment with androgen ablation, radiotherapy, and chemotherapy. In phase I clinical trials, OGX-011 has been well tolerated and a biologically effective dose has been identified in humans.
Study Design
This is an open-label, non-blinded, phase II clinical, tissue pharmacokinetic and pharmacodynamic study of weekly OGX-011 and neoadjuvant hormone therapy prior to radical prostatectomy in patients with localized prostate carcinoma and high-risk features.
Study Objectives
Primary Objectives
- To assess the effects of combined neoadjuvant hormone therapy (NHT) and OGX-011 prior to radical prostatectomy on pathologic complete response rates in men with high risk localized prostate cancer.
Secondary Objectives
- To quantify changes in clusterin expression in residual prostate cancer after treatment with NHT and OGX-011.
- To measure levels of full length OGX-011 in prostate tissues after 3 months of NHT.
- To assess the safety and tolerability toxicity of 3 months of OGX-011 and NHT prior to radical prostatectomy.
- To measure evidence of OGX-011's effect on clusterin expression in patient peripheral blood mononuclear cells (PBMNC).
- To measure evidence of OGX-011's effect on patient clusterin serum levels.
- To assess the effects of combined NHT and OGX-011 on time to PSA nadir.
- To determine PSA recurrence rates after combined NHT and OGX-011.
Key Eligibility Criteria
- Histologically confirmed adenocarcinoma of the prostate, previously untreated
- Potential candidate for radical prostatectomy
- Any one of the following criteria (minimum of 2 positive biopsies):
- Clinical stage T3
- Serum PSA > 10 ng/ml
- Gleason score 7-10
- Gleason score 6 and > 3 positive biopsies
- ECOG performance status 0-1
- WBC ≥ 3.0 x 10^9/L
- Hemoglobin ≥ 100 g/L
- Platelets ≥ 100 x 10^9/L
- PTT, INR, AST, ALT, creatinine, total bilirubin within normal limits
Treatment Plan
Approximately 45 newly diagnosed, previously untreated patients with clinically localized, high-risk prostate carcinoma will be entered into this trial. These patients will receive neoadjuvant hormone therapy (buserelin 9.9 mg subcutaneously x 1 injection with flutamide 250 mg orally T.I.D. for the first 4 weeks only) for 12 weeks in combination with OGX-011 (a 2'MOE phosphorothioate clusterin antisense oligonucleotide) weekly on a 4 week cycle for 3 courses. For week one, cycle one only, OGX-011 will be given on Days 1, 3 and 5. OGX-011 is given at a dose of 640 mg by intravenous infusion over 2 hours. Radical prostatectomy will take place within 14 days of the last dose of OGX-011.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically confirmed adenocarcinoma of the prostate, previously untreated
- Males ≥ 18 years of age.
- Potential candidate for radical prostatectomy
- Any of the following (minimum of 2 positive biopsies):
- ECOG performance status 0-1
Key exclusion criteria (7 listed)
- Prior hormone, radiation, or chemotherapy for prostate cancer
- Evidence of active infection
- Patients receiving therapeutic doses of warfarin or heparin
- Severe end organ disease
- Patients who otherwise would not be candidates for radical prostatectomy because of health or tumour factors
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 |
|---|---|---|
| OGX-011See Detailed Description, Treatment Plan | Biological | – |
Primary outcome
To assess the effects of combined neoadjuvant hormone therapy (NHT) and OGX-011 prior to radical prostatectomy on pathologic complete response rates in men with high risk localized prostate cancer
Time frame: See Detailed Description, Treatment Plan
7 secondary outcomes
To quantify changes in clusterin expression in residual prostate cancer after treatment with NHT and OGX-011
Time frame: See Detailed Description, Treatment Plan
To measure levels of full length OGX-011 in prostate tissues after 3 months of NHT
Time frame: See Detailed Description, Treatment Plan
To assess the safety and tolerability toxicity of 3 months of OGX-011 and NHT prior to radical prostatectomy
Time frame: See Detailed Description, Treatment Plan
To measure evidence of OGX-011's effect on clusterin expression in patient peripheral blood mononuclear cells (PBMNC)
Time frame: See Detailed Description, Treatment Plan
To measure evidence of OGX-011's effect on patient clusterin serum levels
Time frame: See Detailed Description, Treatment Plan
To assess the effects of combined NHT and OGX-011 on time to prostate specific antigen (PSA) nadir
Time frame: See Detailed Description, Treatment Plan
To determine PSA recurrence rates after combined NHT and OGX-011
Time frame: See Detailed Description, Treatment Plan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 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.
Dr. Kim Chi principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OGX-011 in people with Prostate Cancer, run by University of British Columbia at 1 site in Canada.
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 14 inclusion and 7 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the effects of combined neoadjuvant hormone therapy (NHT) and OGX-011 prior to radical prostatectomy on pathologic complete response rates in men with high risk localized prostate cancer (time frame: See Detailed Description, Treatment Plan). 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 3 Mar 2017.