Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01695044
First received: September 25, 2012
Last updated: February 21, 2017
Last verified: February 2017
Results First Received: December 28, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: PSMA ADC

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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 
COMPLETED   17 
NOT COMPLETED   102 



  Baseline Characteristics
  Hide 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
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 
Age 
[Units: Years]
Mean (Full Range)
 70.7 
 (50 to 91) 
 73.1 
 (50 to 87) 
 71.4 
 (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) 
PSA 
[Units: ug/mL]
Median (Full Range)
 188.9 
 (7.5 to 17459.6) 
 94.1 
 (1.4 to 2307.8) 
 162.9 
 (1.4 to 17459.6) 


  Outcome Measures
  Show All 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
  Hide 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
  Hide 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
e-mail: vdipippo@progenics.com



Responsible Party: Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01695044     History of Changes
Other Study ID Numbers: PSMA ADC 2301
Study First Received: September 25, 2012
Results First Received: December 28, 2016
Last Updated: February 21, 2017