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

Sponsor
Nymox Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01620515
Collaborator
(none)
141
Enrollment
23
Locations
3
Arms
44
Actual Duration (Months)
6.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: NX-1207 2.5 mg
  • Drug: NX-1207 15 mg
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
141 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 21, 2012
Actual Primary Completion Date :
Oct 21, 2015
Actual Study Completion Date :
Oct 21, 2015

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Active Surveillance

Subjects with low risk localized (T1c) prostate cancer who are being followed with active surveillance and not undergoing active treatment for prostate cancer.
Experimental: NX-1207 2.5 mg

Drug: NX-1207 2.5 mg
A single intraprostatic injection of NX-1207 2.5 mg followed by active surveillance.
Experimental: NX-1207 15 mg

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

Outcome Measures

Primary Outcome Measures

  1. Undetectable cancer post-treatment in the region of the prostate where the baseline cancer was detected. [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.

  2. 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. [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.

Secondary Outcome Measures

  1. Change in tumor grade in the region of the baseline prostate cancer [Baseline to 45 days post-treatment]

  2. Change in tumor volume in the region of the baseline prostate cancer [Baseline to 45 days post-treatment]

  3. Change in tumor grade for the whole prostate [Baseline to 45 days post-treatment]

  4. Change in tumor volume in the whole prostate [Baseline to 45 days post-treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 85 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 For information concerning this clinical site, please contact Nymox at 800-936-9669. Tucson Arizona United States 85715
2 For information concerning this clinical site, please contact Nymox at 800-936-9669. Atherton California United States 94027
3 For information concerning this clinical site, please contact Nymox at 800-936-9669. La Mesa California United States 91942
4 For information concerning this clinical site, please contact Nymox at 800-936-9669. Long Beach California United States 90806
5 For information concerning this clinical site, please contact Nymox at 800-936-9669. San Diego California United States 92120
6 For information concerning this clinical site, please contact Nymox at 800-936-9669. Denver Colorado United States 80220
7 For information concerning this clinical site, please contact Nymox at 800-936-9669. Englewood Colorado United States 80113
8 For information concerning this clinical site, please contact Nymox at 800-936-9669. New Britain Connecticut United States 06052
9 For information concerning this clinical site, please contact Nymox at 800-936-9669. Aventura Florida United States 33180
10 For information concerning this clinical site, please contact Nymox at 800-936-9669. Naples Florida United States 34102
11 For information concerning this clinical site, please contact Nymox at 800-936-9669. Jeffersonville Indiana United States 47130
12 For information concerning this clinical site, please contact Nymox at 800-936-9669. Shreveport Louisiana United States 71106
13 For information concerning this clinical site, please contact Nymox at 800-936-9669. Annapolis Maryland United States 21401
14 For information concerning this clinical site, please contact Nymox at 800-936-9669. Baltimore Maryland United States 21204
15 For information concerning this clinical site, please contact Nymox at 800-936-9669. Las Vegas Nevada United States 89148
16 For information concerning this clinical site, please contact Nymox at 800-936-9669. Brick New Jersey United States 08724
17 For information concerning this clinical site, please contact Nymox at 800-936-9669. Albuquerque New Mexico United States 87109
18 For information concerning this clinical site, please contact Nymox at 800-936-9669. Garden City New York United States 11530
19 For information concerning this clinical site, please contact Nymox at 800-936-9669. New York New York United States 10016
20 For information concerning this clinical site, please contact Nymox at 800-936-9669. Myrtle Beach South Carolina United States 29572
21 For information concerning this clinical site, please contact Nymox at 800-936-9669. Germantown Tennessee United States 38138
22 For information concerning this clinical site, please contact Nymox at 800-936-9669. Carrollton Texas United States 75010
23 For information concerning this clinical site, please contact Nymox at 800-936-9669. Salt Lake City Utah United States 84124

Sponsors and Collaborators

  • Nymox Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nymox Corporation
ClinicalTrials.gov Identifier:
NCT01620515
Other Study ID Numbers:
  • NX03-0040
First Posted:
Jun 15, 2012
Last Update Posted:
Mar 10, 2017
Last Verified:
Mar 1, 2017
Keywords provided by Nymox Corporation
Prostate
Prostate Cancer
Localized Prostate Cancer
T1c Prostate Cancer
Focal Therapy
NX-1207
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Mar 10, 2017