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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NX-1207 2.5 mg
NX-1207 15 mg
Sponsored by
Nymox Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate, Prostate Cancer, Localized Prostate Cancer, T1c Prostate Cancer, Focal Therapy, NX-1207

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • History of alcohol or substance abuse or dependence within the past 2 years.

Sites / Locations

  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.
  • For information concerning this clinical site, please contact Nymox at 800-936-9669.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Active Surveillance

NX-1207 2.5 mg

NX-1207 15 mg

Arm Description

Subjects with low risk localized (T1c) prostate cancer who are being followed with active surveillance and not undergoing active treatment for prostate cancer.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change in tumor grade in the region of the baseline prostate cancer
Change in tumor volume in the region of the baseline prostate cancer
Change in tumor grade for the whole prostate
Change in tumor volume in the whole prostate

Full Information

First Posted
June 13, 2012
Last Updated
March 9, 2017
Sponsor
Nymox Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01620515
Brief Title
Two-Dose Level Evaluation of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 21, 2012 (Actual)
Primary Completion Date
October 21, 2015 (Actual)
Study Completion Date
October 21, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nymox Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate, Prostate Cancer, Localized Prostate Cancer, T1c Prostate Cancer, Focal Therapy, NX-1207

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Surveillance
Arm Type
No Intervention
Arm Description
Subjects with low risk localized (T1c) prostate cancer who are being followed with active surveillance and not undergoing active treatment for prostate cancer.
Arm Title
NX-1207 2.5 mg
Arm Type
Experimental
Arm Title
NX-1207 15 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NX-1207 2.5 mg
Intervention Description
A single intraprostatic injection of NX-1207 2.5 mg followed by active surveillance.
Intervention Type
Drug
Intervention Name(s)
NX-1207 15 mg
Intervention Description
A single intraprostatic injection of NX-1207 15 mg followed by active surveillance.
Primary Outcome Measure Information:
Title
Undetectable cancer post-treatment in the region of the prostate where the baseline cancer was detected.
Description
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.
Time Frame
Baseline to 45 days post-treatment
Title
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.
Description
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.
Time Frame
Baseline to 60 days post-treatment
Secondary Outcome Measure Information:
Title
Change in tumor grade in the region of the baseline prostate cancer
Time Frame
Baseline to 45 days post-treatment
Title
Change in tumor volume in the region of the baseline prostate cancer
Time Frame
Baseline to 45 days post-treatment
Title
Change in tumor grade for the whole prostate
Time Frame
Baseline to 45 days post-treatment
Title
Change in tumor volume in the whole prostate
Time Frame
Baseline to 45 days post-treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. History of alcohol or substance abuse or dependence within the past 2 years.
Facility Information:
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Atherton
State/Province
California
ZIP/Postal Code
94027
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
Facility Name
For information concerning this clinical site, please contact Nymox at 800-936-9669.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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