NCT01620515|CompletedPhase 2DMC

Two-Dose Level Evaluation of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer

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

Nymox Corporation ClinicalTrials.gov

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1 other identifier

NX03-0040

Study Type

interventional

Target

141

Locations

1 country

Sites

Timeline

RegisteredJun 2012

StartedFeb 2012

CompletionOct 2015

Brief 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. 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

141

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline

Completed

Started Feb 2012

Geographic Reach

1 country

23 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.7 years study duration

Study Start

First participant enrolled

February 21, 2012

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2012

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed

3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2015

Completed

Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

3.7 years

First QC Date

June 13, 2012

Last Update Submit

March 9, 2017

Conditions

Prostate Cancer

Keywords

ProstateProstate CancerLocalized Prostate CancerT1c Prostate CancerFocal TherapyNX-1207

Outcome Measures

Primary Outcomes (2)

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.
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.
Baseline to 60 days post-treatment

Secondary Outcomes (4)

Change in tumor grade in the region of the baseline prostate cancer
Baseline to 45 days post-treatment
Change in tumor volume in the region of the baseline prostate cancer
Baseline to 45 days post-treatment
Change in tumor grade for the whole prostate
Baseline to 45 days post-treatment
Change in tumor volume in the whole prostate
Baseline to 45 days post-treatment

Study Arms (3)

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

Interventions

NX-1207 2.5 mgDRUG

A single intraprostatic injection of NX-1207 2.5 mg followed by active surveillance.

NX-1207 2.5 mg

NX-1207 15 mgDRUG

A single intraprostatic injection of NX-1207 15 mg followed by active surveillance.

NX-1207 15 mg

Eligibility Criteria

Age45 Years - 85 Years

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.
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.
+1 more criteria

Contact the study team to confirm eligibility.