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Effects of Two Doses of MPX Capsules on Rising Prostate-specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01317199
Recruitment Status : Completed
First Posted : March 17, 2011
Results First Posted : July 18, 2018
Last Update Posted : July 18, 2018
Sponsor:
Collaborators:
Howard University
Prostate Cancer Clinical Trials Consortium
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Muscadine Plus Grape Skin Extract
Drug: Low-dose MPX
Drug: High-dose MPX
Drug: Placebo oral capsule

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Recruitment dates:

Phase I: October 4, 2011-August 7, 2012 in medical clinics Phase II: January 31, 2013-October 20, 2014


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Enrolled subjects agreed to abstain from other commercially available Muscadine Plus products while in this trial.

If subjects were taking other dietary/herbal supplements (e.g. saw palmetto, selenium, pomegranate juice or pills, etc) prior to study entry, they had to be on a stable dose for 2 months prior and not stop while on trial.


Reporting Groups
  Description
Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX) Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.
Phase 2: Placebo Control Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).
Phase 2: Low-dose MPX Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).
Phase 2: High-dose MPX Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).

Participant Flow for 2 periods

Period 1:   Dose-escalation Phase 1
    Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX)   Phase 2: Placebo Control   Phase 2: Low-dose MPX   Phase 2: High-dose MPX
STARTED   14   0   0   0 
Cycle 1: 500mg MPX Once Daily for 28 Day   2   0   0   0 
Cycle 2: 1000mg MPX Daily for 28 Days   2   0   0   0 
Cycle 3: 2000mg MPX Daily for 28 Days   2   0   0   0 
Cycle 4: 3000mg MPX Daily for 28 Days   2   0   0   0 
Cycle 5: 4000mg MPX Daily for 28 Days   6   0   0   0 
COMPLETED   7   0   0   0 
NOT COMPLETED   7   0   0   0 
Physician Decision                5                0                0                0 
Disease progression                1                0                0                0 
Comorbidities, myasthenia gravis                1                0                0                0 

Period 2:   Randomized Phase 2
    Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX)   Phase 2: Placebo Control   Phase 2: Low-dose MPX   Phase 2: High-dose MPX
STARTED   0   24   56   49 
COMPLETED   0   13   35   32 
NOT COMPLETED   0   11   21   17 
Disease progression                0                3                7                5 
Withdrawal by Subject                0                3                5                4 
Adverse Event                0                0                0                1 
Comorbidities                0                2                2                2 
Rising PSA, not as defined by protocol                0                2                5                2 
Disenrolled before treatment                0                1                1                2 
Patient stopped taking study drug                0                0                0                1 
Patient transferred to other facility                0                0                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX) Muscadine Plus Grape Skin Extract: Phase I Dose-escalation starts at 500mg daily for 1 cycle (28 days), then increased to 1000mg for 2nd cycle, then increased to 2000mg daily for 3rd cycle, then increased to 3000mg daily for 4th cycle, then increased to maximum dose of 4000mg daily for final cycle. Pills given by mouth once daily for 28 days per cycle.
Phase 2: Placebo Control Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).
Phase 2: Low-dose MPX Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).
Phase 2: High-dose MPX Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
Total Total of all reporting groups

Baseline Measures
   Dose-escalation Phase:Muscadine Plus Grape Skin Extract (MPX)   Phase 2: Placebo Control   Phase 2: Low-dose MPX   Phase 2: High-dose MPX   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   24   56   49   143 
Age 
[Units: Years]
Mean (Standard Deviation)
         
Participants Analyzed   14   24   56   49   143 
   62.6  (7.5)   69  (7.1)   67  (7.2)   68  (6.9)   67.2  (7.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Participants Analyzed   14   24   56   49   143 
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Male      14 100.0%      24 100.0%      56 100.0%      49 100.0%      143 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Participants Analyzed   14   24   56   49   143 
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      4  28.6%      6  25.0%      12  21.4%      10  20.4%      32  22.4% 
White      10  71.4%      18  75.0%      43  76.8%      38  77.6%      109  76.2% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      1   1.8%      1   2.0%      2   1.4% 
Region of Enrollment 
[Units: Participants]
         
United States           
Participants Analyzed   14   24   56   49   143 
United States   14   24   56   49   143 
Eastern Cooperative Oncology Group (ECOG) [1] [2] 
[Units: Participants]
Count of Participants
         
Participants Analyzed   0   23   54   47   124 
       18  78.3%      52  96.3%      39  83.0%      109  87.9% 
       5  21.7%      2   3.7%      8  17.0%      15  12.1% 
[1] The Eastern Cooperative Oncology Group (ECOG) scale is a measure of performance status with 0 (fully active) as the best score and 1 being restricted to physically strenuous activity.
[2] Baseline characteristics were not collected for subjects who withdrew from the study. ECOG was not analyzed in the dose-escalation phase.
Gleason score [1] [2] 
[Units: Participants]
Count of Participants
         
≤6, 3+4           
Participants Analyzed   0   24   56   49   129 
≤6, 3+4      11   25   23   59 
≥8, 4+3           
Participants Analyzed   0   24   56   49   129 
≥8, 4+3      13   31   26   70 
         
Participants Analyzed   14   0   0   0   14 
 3            3 
         
Participants Analyzed   14   0   0   0   14 
 7            7 
         
Participants Analyzed   14   0   0   0   14 
 1            1 
         
Participants Analyzed   14   0   0   0   14 
 3            3 
[1] The gleason score is an indication of prognosis based on prostate pathology. The score ranges from 2 to 10 with a higher score reflecting less-differentiated tumors with worse prognosis. The total score is a sum of two numbers which are based on the microscopic appearance of cells. The first number is the score based on the dominant, cell morphology (scored 1-5) and the second number is based on the highest grade of the non-dominant cell pattern (scored 1-5).
[2] Gleason score was recorded differently in the dose-escalation phase and phase 2.
Baseline PSA doubling time (PSADT) [1] 
[Units: Months]
Mean (Standard Deviation)
         
Participants Analyzed   14   0   0   0   14 
   13  (10.1)            13  (10.1) 
[1] Baseline PSADT was recorded as a mean in the dose-escalation phase, versus as number of participants with greater than or less than 9 months PSADT in Phase 2.
Baseline PSADT [1] 
[Units: Participants]
Count of Participants
         
Participants Analyzed   0   23   55   48   126 
≤9 months         13  56.5%      32  58.2%      27  56.3%      72  57.1% 
>9 months         10  43.5%      23  41.8%      21  43.8%      54  42.9% 
[1] Baseline PSADT was recorded as a mean in the dose-escalation phase, versus as number of participants with greater than or less than 9 months PSADT in Phase 2.
Prior therapy [1] 
[Units: Participants]
Count of Participants
         
Radiation           
Participants Analyzed   14   24   56   49   143 
Radiation   4   21   49   42   116 
Surgery           
Participants Analyzed   14   24   56   49   143 
Surgery   1   16   40   32   89 
Radiation & Surgery           
Participants Analyzed   14   0   0   0   14 
Radiation & Surgery   9            9 
Cryotherapy           
Participants Analyzed   0   24   56   49   129 
Cryotherapy      0   49   1   50 
Brachytherapy           
Participants Analyzed   0   24   56   49   129 
Brachytherapy      3   5   3   11 
Androgen Deprivation Therapy (ADT)           
Participants Analyzed   0   24   56   49   129 
Androgen Deprivation Therapy (ADT)      2   25   19   46 
[1] Participants in Phase 2 were not categorized as 'Radiation & Surgery'. Only individual counts for each prior therapy received was recorded.
Superoxide dismutase 2 (SOD2) genotype [1] 
[Units: Participants]
Count of Participants
         
Alanine/Alanine (Ala/Ala)           
Participants Analyzed   0   21   44   37   102 
Alanine/Alanine (Ala/Ala)      5   12   10   27 
Alanine/Valine (Ala/Val)           
Participants Analyzed   0   24   56   49   129 
Alanine/Valine (Ala/Val)      11   21   22   54 
Valine/Valine (Val/Val)           
Participants Analyzed   0   24   56   49   129 
Valine/Valine (Val/Val)      5   11   5   21 
[1] SOD2 genotype was not recorded in dose-escalation phase. In Phase 2, SOD2 genotype was not recorded for all participants if data was unavailable.


  Outcome Measures

1.  Primary:   (Phase I) Maximum Tolerated Dose   [ Time Frame: Up to 7 months post-intervention ]

2.  Primary:   (Phase II) Prostate Specific Antigen Doubling Time (PSADT)   [ Time Frame: Change from baseline to month 12 ]

3.  Secondary:   Number of Participants With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: At month 12 post-intervention ]

4.  Secondary:   (Phase II) Proportion of Men Whose PSADT Increases Greater Than 33%   [ Time Frame: At month 12 post-intervention ]

5.  Secondary:   (Phase II) Number of Men With Greater Than 50% Reduction in PSA Compared to Baseline   [ Time Frame: At month 12 post-intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Channing Paller
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
phone: 410-955-8239
e-mail: cpaller1@jhmi.edu



Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01317199     History of Changes
Other Study ID Numbers: J1161
First Submitted: March 11, 2011
First Posted: March 17, 2011
Results First Submitted: May 14, 2018
Results First Posted: July 18, 2018
Last Update Posted: July 18, 2018