A Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01695044
Recruitment Status : Completed
First Posted : September 27, 2012
Results First Posted : February 23, 2017
Last Update Posted : March 24, 2017
Information provided by (Responsible Party):
Progenics Pharmaceuticals, Inc.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: PSMA ADC

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Arm 1: PSMA ADC PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.

Participant Flow:   Overall Study
    Arm 1: PSMA ADC
STARTED   119 

  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.
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Reporting Groups
Arm 1: PSMA ADC Chemotherapy-experienced PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.
Arm 2: PSMA ADC Chemotherapy-naive PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.
Total Total of all reporting groups

Baseline Measures
   Arm 1: PSMA ADC Chemotherapy-experienced   Arm 2: PSMA ADC Chemotherapy-naive   Total 
Overall Participants Analyzed 
[Units: Participants]
 84   35   119 
[Units: Years]
Mean (Full Range)
 (50 to 91) 
 (50 to 87) 
 (50 to 91) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      0   0.0%      0   0.0%      0   0.0% 
Male      84 100.0%      35 100.0%      119 100.0% 
Prostate specific antigen (PSA) 
[Units: ug/mL]
Mean (Standard Deviation)
 804.8  (2173.38)   220.9  (438.35)   633.1  (1857.2) 
[Units: ug/mL]
Median (Full Range)
 (7.5 to 17459.6) 
 (1.4 to 2307.8) 
 (1.4 to 17459.6) 

  Outcome Measures

1.  Primary:   Percentage of Participants With Total Serum PSA Response   [ Time Frame: 24 Weeks ]

2.  Primary:   CTC Response   [ Time Frame: 24 Weeks ]

3.  Primary:   Overall Radiologic Response   [ Time Frame: 24 weeks ]

  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
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.

Results Point of Contact:  
Name/Title: Dr. Vincent A. DiPippo
Organization: Progenics Pharmaceuticals, Inc.
phone: (646) 975-2502

Responsible Party: Progenics Pharmaceuticals, Inc. Identifier: NCT01695044     History of Changes
Other Study ID Numbers: PSMA ADC 2301
First Submitted: September 25, 2012
First Posted: September 27, 2012
Results First Submitted: December 28, 2016
Results First Posted: February 23, 2017
Last Update Posted: March 24, 2017