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A Phase 3 Comparative Study of TAP-144-SR(6M) in Prostate Cancer Patients Previously Treated With Hormonal Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01546623
First received: February 28, 2012
Last updated: June 24, 2015
Last verified: June 2015
Results First Received: April 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: TAP-144-SR(6M)
Drug: TAP-144-SR(3M)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants took part in the study at 23 investigative sites in Japan from 11 April 2012 to 04 April 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prostate cancer patients previously treated with hormonal therapy were enrolled in 1 of 2 treatment groups. Two patients withdrew from the period between randomization and starting study drugs (1 in TAP-144-SR(6M) arm and 1 in TAP-144-SR(3M) arm).

Reporting Groups
  Description
TAP-144-SR(6M) TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
TAP-144-SR(3M) TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.

Participant Flow:   Overall Study
    TAP-144-SR(6M)     TAP-144-SR(3M)  
STARTED     82     80  
Received Study Drug     81     79  
COMPLETED     76     74  
NOT COMPLETED     6     6  
Adverse Event                 2                 3  
Major Protocol Deviation                 1                 1  
High Prostate specific antigen                 2                 1  
Did Not Receive Study Drug                 1                 1  



  Baseline Characteristics
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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.
The population included all participants who were randomized to treatment.

Reporting Groups
  Description
TAP-144-SR(6M) TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
TAP-144-SR(3M) TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
Total Total of all reporting groups

Baseline Measures
    TAP-144-SR(6M)     TAP-144-SR(3M)     Total  
Number of Participants  
[units: participants]
  82     80     162  
Age  
[units: Years]
Mean (Standard Deviation)
  73.3  (6.32)     72.6  (6.49)     73.0  (6.39)  
Gender  
[units: Participants]
     
Female     0     0     0  
Male     82     80     162  
Weight  
[units: kg]
Mean (Standard Deviation)
  64.03  (8.689)     65.83  (8.098)     64.92  (8.424)  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean (Standard Deviation)
  23.61  (2.731)     24.32  (2.769)     23.96  (2.764)  
Gleason Score [1]
[units: Participants]
     
2     0     0     0  
3     0     0     0  
4     0     0     0  
5     2     2     4  
6     8     7     15  
7     35     29     64  
8     14     21     35  
9     20     21     41  
10     3     0     3  
Tumor-node-metastasis (TNM) classification at diagnosis: T [2]
[units: Participants]
     
T0     0     0     0  
T1     17     16     33  
T2     32     24     56  
T3     29     33     62  
T4     4     6     10  
TX     0     0     0  
Unknown     0     0     0  
TNM classification at diagnosis: N [3]
[units: Participant]
     
N0     69     62     131  
N1     13     17     30  
NX     0     0     0  
Unknown     0     0     0  
TNM classification at diagnosis: M [4]
[units: participants]
     
M0     63     62     125  
M1     19     17     36  
Unknown     0     0     0  
Period between date of first dianosis and date of informed consent  
[units: Years]
Mean (Standard Deviation)
  1.653  (2.0866)     1.748  (2.0410)     1.700  (2.0583)  
Period between first dose dates of leuproride acetate (over-the-counter) and the study drug  
[units: Weeks]
Mean (Standard Deviation)
  46.328  (20.0833)     46.595  (20.8584)     46.460  (20.4056)  
Eastern Cooperative Oncology Group (ECOG) Performance Status [5]
[units: Participants]
     
0     73     71     144  
1     7     7     14  
2     1     1     2  
3     0     0     0  
4     0     0     0  
[1] Gleason score is a score used in prostate cancer grading. Prostate cancer staging is the process by which physicians categorize the risk of cancer having spread beyond the prostate, or equivalently, the probability of being cured with local therapies such as surgery or radiation. Gleason score are often grouped into four stages (I–IV) of prostate cancer. Gleason scores range from 2 to 10, with 2 representing the most well-differentiated tumors and 10 the least-differentiated tumors.
[2]

Number of participants for whom TNM classification at diagnosis: T data is available in the TAP-144-SR(3M) treatment arm is 79, respectively.

The categories of T is ranged from T1 (better) to T4 (worse). Tx represents "tumor cannot be evaluated" and T0 represents "no signs of tumor."

[3] Number of participants for whom TNM classification at diagnosis: N data is available in the TAP-144-SR(3M) treatment arm is 79, respectively. The categories of N is represented by Nx (lymph nodes cannot be evaluated), N0 (tumor cells absent from regional lymph nodes), and N1 (regional lymph node metastasis present).
[4] Number of participants for whom TNM classification at diagnosis: M data is available in the TAP-144-SR(3M) treatment arm is 79, respectively. The categories of M is represented by M0 (no distant metastasis), and M1 (metastasis to distant organs (beyond regional lymph nodes).
[5] Number of participants for whom ECOG Performance Status data is available in Baseline Characteristics is 81 and 79 in each treatment arm, respectively. The categories of ECOG Performance Status is represented from 0 (Fully active, better) to 4 (Completely disabled, worse).



  Outcome Measures
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1.  Primary:   The Rate of Suppression of Serum Testosterone to Castrate Level   [ Time Frame: From the start of study drug administration through Week 48 ]

2.  Secondary:   Time Course of Changes in Serum Testosterone   [ Time Frame: From baseline to Week 48 ]

3.  Secondary:   Time Course of Changes in Serum Luteinizing Hormone (LH)   [ Time Frame: From baseline to Week 48 ]

4.  Secondary:   Time Course of Changes in Serum Follicle-stimulating Hormone (FSH)   [ Time Frame: From baseline to Week 48 ]

5.  Secondary:   Time Course of Change Rate in Serum PSA (FAS)   [ Time Frame: From baseline to Week 48 ]

6.  Secondary:   The Maximum Rate of Change in PSA Suppression (FAS)   [ Time Frame: From baseline to Week 48 ]

7.  Secondary:   Percentage of Participants With Progression by PSA (FAS)   [ Time Frame: From baseline to Week 48 ]

8.  Secondary:   Soft Tissue Response   [ Time Frame: At week 48 ]

9.  Secondary:   Bone Lesion Response   [ Time Frame: At Week 48 ]

10.  Secondary:   Serum Unchanged TAP-144 Level   [ Time Frame: From baseline to Week 48 ]

11.  Secondary:   12-lead ECG   [ Time Frame: At 1 hour, week 24, and week 48 after administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director, Clinical Science
Organization: Takeda
phone: 800-778-2860
e-mail: trialdisclosures@takeda.com



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01546623     History of Changes
Other Study ID Numbers: TAP-144-SR(6M)IP/CPH-002
U1111-1128-6861 ( Registry Identifier: WHO )
JapicCTI-121763 ( Registry Identifier: JapicCTI )
Study First Received: February 28, 2012
Results First Received: April 2, 2015
Last Updated: June 24, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare