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

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ClinicalTrials.gov Identifier: NCT01695044
Recruitment Status : Completed
First Posted : September 27, 2012
Results First Posted : February 23, 2017
Last Update Posted : March 24, 2017
Sponsor:
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
Enrollment 119
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: PSMA ADC
Hide Arm/Group Description PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.
Period Title: Overall Study
Started 119
Completed 17
Not Completed 102
Arm/Group Title Arm 1: PSMA ADC Chemotherapy-experienced Arm 2: PSMA ADC Chemotherapy-naive Total
Hide Arm/Group Description PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles. PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles. Total of all reporting groups
Overall Number of Baseline Participants 84 35 119
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 84 participants 35 participants 119 participants
70.7
(50 to 91)
73.1
(50 to 87)
71.4
(50 to 91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 35 participants 119 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)  
Mean (Standard Deviation)
Unit of measure:  ug/mL
Number Analyzed 84 participants 35 participants 119 participants
804.8  (2173.38) 220.9  (438.35) 633.1  (1857.2)
PSA  
Median (Full Range)
Unit of measure:  ug/mL
Number Analyzed 84 participants 35 participants 119 participants
188.9
(7.5 to 17459.6)
94.1
(1.4 to 2307.8)
162.9
(1.4 to 17459.6)
1.Primary Outcome
Title Percentage of Participants With Total Serum PSA Response
Hide Description Total serum prostate-specific antigen (PSA) response was defined as any decrease from baseline of at least 30% or 50%.
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The population examined was those subjects with a PSA baseline value and at least one post-baseline value.
Arm/Group Title PSMA ADC Chemotherapy-experienced Chemotherapy-naive
Hide Arm/Group Description:

Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) administered IV at 2.3 mg/kg Q3W for 8 cycles.

The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).

Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) administered IV at 2.3 mg/kg Q3W for 8 cycles.

The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.

Overall Number of Participants Analyzed 79 34
Measure Type: Number
Unit of Measure: % of responders
>30% Decrease in PSA 29 32
>50% Decrease in PSA 11 21
2.Primary Outcome
Title CTC Response
Hide Description Circulating tumor cells (CTC) response was examined at two levels: at least 30% decrease or at least 50% decrease in CTC levels. Response was defined as any decrease from baseline of at least 30% or 50%.
Time Frame 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The population examined was those subjects with a CTC baseline value and at least one post-baseline value.
Arm/Group Title PSMA ADC Chemotherapy-experienced Chemotherapy-naive
Hide Arm/Group Description:

PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.

The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).

PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.

The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.

Overall Number of Participants Analyzed 68 26
Measure Type: Number
Unit of Measure: % of responders
>30% Decrease in CTC 81 92
>50% Decrease in CTC 74 85
3.Primary Outcome
Title Overall Radiologic Response
Hide Description Overall radiologic response was measured prior to the first dose of study drug, at predose of cycle 5, and at the end of study. Imaging techniques used at screening were used throughout the study. The preferred imaging techniques include: bone scan, contrast enhanced CT of chest, contrast enhanced CT of pelvis, and contrast enhanced CT of upper & lower abdomen. Best overall radiologic response (confirmed), target and non-target lesions, was defined as responses in bone, visceral or nodal metastases according to the Modified Response Evaluation Criteria (RECIST 1.1). The best overall radiologic response is the best response recorded from the start of the treatment until disease progression/recurrence (taking, as reference for progressive disease, the smallest measurements recorded since the treatment started). The subject’s best response assignment depended on the achievement of both measurement and confirmation criteria.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The full modified Intention-to-Treat (mITT) population (n = 119) was examined.
Arm/Group Title PSMA ADC Chemotherapy-experienced Chemotherapy-naive
Hide Arm/Group Description:

PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.

The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).

PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.

The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.

Overall Number of Participants Analyzed 84 35
Measure Type: Number
Unit of Measure: % of subjects
Non-evaluable 26 17
Partial response 0 6
Progressive disease 13 9
Stable disease 61 69
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PSMA ADC Chemotherapy-experienced Chemotherapy-naive
Hide Arm/Group Description PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles. The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation). PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles. The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.
All-Cause Mortality
PSMA ADC Chemotherapy-experienced Chemotherapy-naive
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PSMA ADC Chemotherapy-experienced Chemotherapy-naive
Affected / at Risk (%) Affected / at Risk (%)
Total   43/84 (51.19%)   18/35 (51.43%) 
Blood and lymphatic system disorders     
Anemia  1  4/84 (4.76%)  0/35 (0.00%) 
Febrile neutropenia  1  2/84 (2.38%)  3/35 (8.57%) 
Neutropenia  1  2/84 (2.38%)  0/35 (0.00%) 
Hemorrhagic anemia  1  1/84 (1.19%)  0/35 (0.00%) 
Cardiac disorders     
Sinus tachycardia  1  2/84 (2.38%)  0/35 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  3/84 (3.57%)  0/35 (0.00%) 
Constipation  1  2/84 (2.38%)  2/35 (5.71%) 
Ileus  1  2/84 (2.38%)  1/35 (2.86%) 
General disorders     
Asthenia  1  3/84 (3.57%)  0/35 (0.00%) 
Fatigue  1  3/84 (3.57%)  1/35 (2.86%) 
Non-cardiac chest pain  1  2/84 (2.38%)  0/35 (0.00%) 
Infections and infestations     
Bacteremia  1  2/84 (2.38%)  0/35 (0.00%) 
Lobar pneumonia  1  2/84 (2.38%)  0/35 (0.00%) 
Pneumonia  1  3/84 (3.57%)  0/35 (0.00%) 
Sepsis  1  2/84 (2.38%)  1/35 (2.86%) 
Investigations     
ECG QT prolonged  1  2/84 (2.38%)  0/35 (0.00%) 
Decreased neutrophil count  1  3/84 (3.57%)  0/35 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  3/84 (3.57%)  5/35 (14.29%) 
Hyponatremia  1  3/84 (3.57%)  2/35 (5.71%) 
Hypophosphatemia  1  2/84 (2.38%)  1/35 (2.86%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  2/84 (2.38%)  0/35 (0.00%) 
Bone pain  1  3/84 (3.57%)  0/35 (0.00%) 
Muscular weakness  1  3/84 (3.57%)  0/35 (0.00%) 
Nervous system disorders     
Transient ischemic attack  1  0/84 (0.00%)  2/35 (5.71%) 
Renal and urinary disorders     
Hematuria  1  1/84 (1.19%)  2/35 (5.71%) 
Acute renal failure  1  1/84 (1.19%)  2/35 (5.71%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  4/84 (4.76%)  0/35 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  1/84 (1.19%)  2/35 (5.71%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA®, Version 15
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PSMA ADC Chemotherapy-experienced Chemotherapy-naive
Affected / at Risk (%) Affected / at Risk (%)
Total   84/84 (100.00%)   35/35 (100.00%) 
Blood and lymphatic system disorders     
Anemia  1  25/84 (29.76%)  7/35 (20.00%) 
Febrile neutropenia  1  2/84 (2.38%)  3/35 (8.57%) 
Leukopenia  1  3/84 (3.57%)  2/35 (5.71%) 
Neutropenia  1  16/84 (19.05%)  6/35 (17.14%) 
Cardiac disorders     
Tachycardia  1  2/84 (2.38%)  2/35 (5.71%) 
Vertigo  1  3/84 (3.57%)  2/35 (5.71%) 
Eye disorders     
Vision blurred  1  0/84 (0.00%)  2/35 (5.71%) 
Gastrointestinal disorders     
Nausea  1  41/84 (48.81%)  23/35 (65.71%) 
Diarrhea  1  33/84 (39.29%)  16/35 (45.71%) 
Constipation  1  30/84 (35.71%)  12/35 (34.29%) 
Vomiting  1  22/84 (26.19%)  12/35 (34.29%) 
Abdominal pain  1  15/84 (17.86%)  5/35 (14.29%) 
Dyspepsia  1  7/84 (8.33%)  6/35 (17.14%) 
Abdominal pain upper  1  5/84 (5.95%)  0/35 (0.00%) 
Dysphagia  1  3/84 (3.57%)  2/35 (5.71%) 
Flatulence  1  4/84 (4.76%)  2/35 (5.71%) 
Gastroesophageal reflux disease  1  8/84 (9.52%)  1/35 (2.86%) 
General disorders     
Fatigue  1  52/84 (61.90%)  19/35 (54.29%) 
Peripheral edema  1  18/84 (21.43%)  4/35 (11.43%) 
Asthenia  1  13/84 (15.48%)  3/35 (8.57%) 
Pain  1  9/84 (10.71%)  3/35 (8.57%) 
Chills  1  4/84 (4.76%)  2/35 (5.71%) 
Gait disturbance  1  5/84 (5.95%)  2/35 (5.71%) 
Pyrexia  1  6/84 (7.14%)  2/35 (5.71%) 
Infections and infestations     
Urinary tract infection  1  9/84 (10.71%)  4/35 (11.43%) 
Upper resiratory tract infection  1  2/84 (2.38%)  2/35 (5.71%) 
Injury, poisoning and procedural complications     
Fall  1  7/84 (8.33%)  7/35 (20.00%) 
Excoriation  1  1/84 (1.19%)  2/35 (5.71%) 
Infusion related reaction  1  5/84 (5.95%)  1/35 (2.86%) 
Investigations     
Aspartate aminotransferase increased  1  18/84 (21.43%)  1/35 (2.86%) 
Decreased neutrophil count  1  14/84 (16.67%)  3/35 (8.57%) 
Decreased weight  1  14/84 (16.67%)  8/35 (22.86%) 
Alanine aminotransferase increased  1  10/84 (11.90%)  1/35 (2.86%) 
White blood cell count decreased  1  10/84 (11.90%)  0/35 (0.00%) 
Blood alkaline phosphatase increased  1  8/84 (9.52%)  1/35 (2.86%) 
Lymphocyte count decreased  1  5/84 (5.95%)  0/35 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  40/84 (47.62%)  15/35 (42.86%) 
Dehydration  1  20/84 (23.81%)  6/35 (17.14%) 
Hypophosphatemia  1  15/84 (17.86%)  2/35 (5.71%) 
Hypokalemia  1  14/84 (16.67%)  11/35 (31.43%) 
Hypocalcemia  1  13/84 (15.48%)  2/35 (5.71%) 
Hyponatremia  1  13/84 (15.48%)  4/35 (11.43%) 
Hyperglycemia  1  12/84 (14.29%)  2/35 (5.71%) 
Hypoalbuminemia  1  9/84 (10.71%)  0/35 (0.00%) 
Hypomagnesemia  1  4/84 (4.76%)  2/35 (5.71%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness  1  19/84 (22.62%)  11/35 (31.43%) 
Back pain  1  15/84 (17.86%)  4/35 (11.43%) 
Myalgia  1  14/84 (16.67%)  7/35 (20.00%) 
Arthralgia  1  10/84 (11.90%)  4/35 (11.43%) 
Bone pain  1  10/84 (11.90%)  4/35 (11.43%) 
Musculoskeletal pain  1  5/84 (5.95%)  3/35 (8.57%) 
Pain in extremity  1  6/84 (7.14%)  3/35 (8.57%) 
Nervous system disorders     
Peripheral neuropathy  1  31/84 (36.90%)  13/35 (37.14%) 
Headache  1  17/84 (20.24%)  3/35 (8.57%) 
Dizziness  1  11/84 (13.10%)  6/35 (17.14%) 
Peripheral sensory neuropathy  1  7/84 (8.33%)  8/35 (22.86%) 
Dysgeusia  1  5/84 (5.95%)  6/35 (17.14%) 
Ataxia  1  3/84 (3.57%)  2/35 (5.71%) 
Paraesthesia  1  5/84 (5.95%)  1/35 (2.86%) 
Sciatica  1  0/84 (0.00%)  2/35 (5.71%) 
Transient ischemic attack  1  0/84 (0.00%)  2/35 (5.71%) 
Psychiatric disorders     
Insomnia  1  18/84 (21.43%)  6/35 (17.14%) 
Depression  1  3/84 (3.57%)  5/35 (14.29%) 
Anxiety  1  5/84 (5.95%)  3/35 (8.57%) 
Confusional state  1  5/84 (5.95%)  1/35 (2.86%) 
Renal and urinary disorders     
Hematuria  1  4/84 (4.76%)  2/35 (5.71%) 
Proteinuria  1  5/84 (5.95%)  0/35 (0.00%) 
Acute renal failure  1  1/84 (1.19%)  3/35 (8.57%) 
Urinary incontinence  1  3/84 (3.57%)  2/35 (5.71%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  19/84 (22.62%)  2/35 (5.71%) 
Cough  1  7/84 (8.33%)  3/35 (8.57%) 
Pleural effusion  1  2/84 (2.38%)  2/35 (5.71%) 
Productive cough  1  7/84 (8.33%)  0/35 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  12/84 (14.29%)  5/35 (14.29%) 
Rash  1  4/84 (4.76%)  4/35 (11.43%) 
Pruritus  1  1/84 (1.19%)  3/35 (8.57%) 
Vascular disorders     
Deep vein thrombosis  1  3/84 (3.57%)  2/35 (5.71%) 
Hypertension  1  2/84 (2.38%)  2/35 (5.71%) 
Hypotension  1  5/84 (5.95%)  2/35 (5.71%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA®, Version 15
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.
ClinicalTrials.gov 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