Prostate CancerPhase 2NCT01620515
Two-Dose Level Evaluation of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer
A Phase 2 study testing NX-1207 2.5 mg and NX-1207 15 mg in people with Prostate Cancer, run by Nymox Corporation at 23 sites in United States.
Trial summary
This study is designed to evaluate the safety and efficacy of a single injection of NX-1207 for the treatment of biopsy-confirmed low risk localized (T1c) prostate cancer in patients currently undergoing active surveillance. Read more about this study
- Who is it for?
- Ages 45 to 85 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- NX-1207 2.5 mg and NX-1207 15 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 23 sitesUnited States
- Study dates
- 21 Feb 2012to 21 Oct 2015
- 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 45 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T1c prostate cancer
- Gleason score ≤ 6 with no Gleason pattern of 4 or 5.
- Life expectancy ≥ 5 years.
- Single positive prostate biopsy core with ≤ 50% cancer
- PSA ≤ 10 ng/mL
Who cannot join
- Previous active treatment (such as surgery, brachytherapy, radiotherapy) for prostate cancer.
- Evidence of metastatic disease or previous positive bone scan.
- Previous hormonal therapy for prostate cancer.
- Use of certain concomitant medications, including 5 alpha reductase inhibitors (e.g. finasteride, dutasteride), androgen receptor blockers (e.g. flutamide, bicalutamide), immunosuppressants(such as Imuran™, Enbrel™, Remicade™, Humira™, etc.), anticoagulants(such as Coumadin™ or heparin), or chemotherapeutics.
- Previous surgical or invasive prostate treatments such as TURP, TUMT, TUNA, laser or any other minimally invasive treatment within the past 12 months.
- Pelvic irradiation.
Show all 16Show fewer
- Urinary tract infection more than once in the past 12 months.
- Acute or chronic prostatitis in the past 12 months.
- Clinically significant renal or hepatic impairment.
- Bleeding disorder.
- Poorly controlled diabetes type 1 or type 2.
- Urinary retention in the previous 12 months.
- Self-catheterization for urinary retention.
- Post-void residual urine volume > 200 mL.
- Prior significant rectal surgery or any rectal condition with rectal stenosis or fistula.
- History of alcohol or substance abuse or dependence within the past 2 years.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Albuquerque, New Mexico, 87109
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Annapolis, Maryland, 21401
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Atherton, California, 94027
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Aventura, Florida, 33180
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Baltimore, Maryland, 21204
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Brick, New Jersey, 08724
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Carrollton, Texas, 75010
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Denver, Colorado, 80220
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Englewood, Colorado, 80113
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Garden City, New York, 11530
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Germantown, Tennessee, 38138
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Jeffersonville, Indiana, 47130
For information concerning this clinical site, please contact Nymox at 800-936-9669.
La Mesa, California, 91942
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Las Vegas, Nevada, 89148
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Long Beach, California, 90806
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Myrtle Beach, South Carolina, 29572
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Naples, Florida, 34102
For information concerning this clinical site, please contact Nymox at 800-936-9669.
New Britain, Connecticut, 06052
For information concerning this clinical site, please contact Nymox at 800-936-9669.
New York, New York, 10016
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Salt Lake City, Utah, 84124
For information concerning this clinical site, please contact Nymox at 800-936-9669.
San Diego, California, 92120
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Shreveport, Louisiana, 71106
For information concerning this clinical site, please contact Nymox at 800-936-9669.
Tucson, Arizona, 85715
About this study
Official title: Phase 2 Multicenter Prospective Open Label 2-Dose Level Clinical Safety and Efficacy Evaluation of Injection of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer
This study is designed to evaluate the safety and efficacy of a single injection of NX-1207 for the treatment of biopsy-confirmed low risk localized (T1c) prostate cancer in patients currently undergoing active surveillance. Study participants currently on active surveillance will be randomized either to treatment with a single intraprostatic injection of NX-1207 (2.5 mg or 15 mg) followed by active surveillance or to no treatment (continued active surveillance). Blinded efficacy evaluation will be by a second post-treatment prostate biopsy.
- Conditions
- Prostate Cancer
- Being tested
- NX-1207 2.5 mg, NX-1207 15 mg
- Keywords
- Prostate, Prostate Cancer, Localized Prostate Cancer, T1c Prostate Cancer, Focal Therapy, NX-1207
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NX-1207 2.5 mgDrug
A single intraprostatic injection of NX-1207 2.5 mg followed by active surveillance.
NX-1207 15 mgDrug
A single intraprostatic injection of NX-1207 15 mg followed by active surveillance.
| Study group | Role | What they receive |
|---|---|---|
| Active Surveillance | No intervention | Subjects with low risk localized (T1c) prostate cancer who are being followed with active surveillance and not undergoing active treatment for prostate cancer. |
| NX-1207 2.5 mg | Experimental | Not described Receives: Drug: NX-1207 2.5 mg |
| NX-1207 15 mg | Experimental | Not described Receives: Drug: NX-1207 15 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undetectable cancer post-treatment in the region of the prostate where the baseline cancer was detected.
The primary efficacy endpoint is the percentage of subjects with undetectable prostate cancer (negative biopsy) in the region of the prostate where the baseline cancer was detected.
Measured: Baseline to 45 days post-treatment
Safety of a single treatment of NX-1207 2.5 mg or NX-1207 15 mg in subjects with biopsy-confirmed low grade low risk localized (T1c) prostate cancer.
Safety will be assessed by physical exam, prostate biopsy, monitoring of adverse events, changes in ECG, and changes in PSA and other clinical laboratory values.
Measured: Baseline to 60 days post-treatment
Secondary outcomes (4)
Change in tumor grade in the region of the baseline prostate cancer
Measured: Baseline to 45 days post-treatment
Change in tumor volume in the region of the baseline prostate cancer
Measured: Baseline to 45 days post-treatment
Change in tumor grade for the whole prostate
Measured: Baseline to 45 days post-treatment
Change in tumor volume in the whole prostate
Measured: Baseline to 45 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study start21 Feb 2012
- Primary completion21 Oct 2015
- Study completion21 Oct 2015
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.
- 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
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nymox Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620515
- Sponsor's protocol ID
- NX03-0040
- Status last verified
- Mar 2017
- First submitted
- 13 Jun 2012
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Multicenter Prospective Open Label 2-Dose Level Clinical Safety and Efficacy Evaluation of Injection of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer
- ClinicalTrials.gov ID
- NCT01620515
- Acronym / sponsor ID
- NX03-0040
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Prostate Cancer, Localized Prostate Cancer, T1c Prostate Cancer, Focal Therapy, NX-1207
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Nymox CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2012 (actual)
- Primary completion
- 21 Oct 2015 (actual)
- Study completion
- 21 Oct 2015 (actual)
- First posted
- 15 Jun 2012 (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 is designed to evaluate the safety and efficacy of a single injection of NX-1207 for the treatment of biopsy-confirmed low risk localized (T1c) prostate cancer in patients currently undergoing active surveillance. Study participants currently on active surveillance will be randomized either to treatment with a single intraprostatic injection of NX-1207 (2.5 mg or 15 mg) followed by active surveillance or to no treatment (continued active surveillance). Blinded efficacy evaluation will be by a second post-treatment prostate biopsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Surveillance | No intervention | –Subjects with low risk localized (T1c) prostate cancer who are being followed with active surveillance and not undergoing active treatment for prostate cancer. |
| NX-1207 2.5 mg | Experimental | Drug: NX-1207 2.5 mg |
| NX-1207 15 mg | Experimental | Drug: NX-1207 15 mg |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- T1c prostate cancer
- Gleason score ≤ 6 with no Gleason pattern of 4 or 5.
- Life expectancy ≥ 5 years.
- Single positive prostate biopsy core with ≤ 50% cancer
- PSA ≤ 10 ng/mL
Key exclusion criteria (16 listed)
- Previous active treatment (such as surgery, brachytherapy, radiotherapy) for prostate cancer.
- Evidence of metastatic disease or previous positive bone scan.
- Previous hormonal therapy for prostate cancer.
- Use of certain concomitant medications, including 5 alpha reductase inhibitors (e.g. finasteride, dutasteride), androgen receptor blockers (e.g. flutamide, bicalutamide), immunosuppressants(such as Imuran™, Enbrel™, Remicade™, Humira™, etc.), anticoagulants(such as Coumadin™ or heparin), or chemotherapeutics.
- Previous surgical or invasive prostate treatments such as TURP, TUMT, TUNA, laser or any other minimally invasive treatment within the past 12 months.
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 |
|---|---|---|
| NX-1207 2.5 mgA single intraprostatic injection of NX-1207 2.5 mg followed by active surveillance. | Drug | NX-1207 2.5 mg |
| NX-1207 15 mgA single intraprostatic injection of NX-1207 15 mg followed by active surveillance. | Drug | NX-1207 15 mg |
Primary outcome
Undetectable cancer post-treatment in the region of the prostate where the baseline cancer was detected.
Time frame: Baseline to 45 days post-treatment
The primary efficacy endpoint is the percentage of subjects with undetectable prostate cancer (negative biopsy) in the region of the prostate where the baseline cancer was detected.
Safety of a single treatment of NX-1207 2.5 mg or NX-1207 15 mg in subjects with biopsy-confirmed low grade low risk localized (T1c) prostate cancer.
Time frame: Baseline to 60 days post-treatment
Safety will be assessed by physical exam, prostate biopsy, monitoring of adverse events, changes in ECG, and changes in PSA and other clinical laboratory values.
4 secondary outcomes
Change in tumor grade in the region of the baseline prostate cancer
Time frame: Baseline to 45 days post-treatment
Change in tumor volume in the region of the baseline prostate cancer
Time frame: Baseline to 45 days post-treatment
Change in tumor grade for the whole prostate
Time frame: Baseline to 45 days post-treatment
Change in tumor volume in the whole prostate
Time frame: Baseline to 45 days post-treatment
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 10 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.
The record lists no contact. Use the official record to reach the sponsor.
23 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 NX-1207 2.5 mg and NX-1207 15 mg in people with Prostate Cancer, run by Nymox Corporation at 23 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 5 inclusion and 16 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 10 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 23 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. 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?
Undetectable cancer post-treatment in the region of the prostate where the baseline cancer was detected. (time frame: Baseline to 45 days post-treatment). The study lists 2 primary outcomes in all. 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 10 Mar 2017.