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Samarium-153 With Neoadjuvant Hormonal and Radiation Therapy for Locally Advanced Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00328614
Recruitment Status : Completed
First Posted : May 22, 2006
Results First Posted : November 8, 2013
Last Update Posted : November 29, 2016
Sponsor:
Collaborator:
Cytogen Corporation
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: Samarium-153
Drug: Total Androgen Suppression (TAS) with Bicalutamide
Drug: Total androgen suppression (TAS) with Goserelin Acetate
Device: Radiation Therapy
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Samarium-153 (0.25 mCi/kg) Samarium-153 (0.5 mCi/kg) Samarium-153 (0.75 mCi/kg) Samarium-153 (1.0 mCi/kg) Samarium-153 (1.5 mCi/kg) Samarium-153 (2.0 mCi/kg)
Hide Arm/Group Description Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
Period Title: Overall Study
Started 4 4 6 6 6 6
Completed 4 4 6 5 5 5
Not Completed 0 0 0 1 1 1
Arm/Group Title Samarium-153 (0.25 mCi/kg) Samarium-153 (0.5 mCi/kg) Samarium-153 (0.75 mCi/kg) Samarium-153 (1.0 mCi/kg) Samarium-153 (1.5 mCi/kg) Samarium-153 (2.0 mCi/kg) Total
Hide Arm/Group Description Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy Total of all reporting groups
Overall Number of Baseline Participants 4 4 6 6 6 6 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 6 participants 6 participants 6 participants 6 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
1
  25.0%
3
  50.0%
1
  16.7%
3
  50.0%
2
  33.3%
10
  31.3%
>=65 years
4
 100.0%
3
  75.0%
3
  50.0%
5
  83.3%
3
  50.0%
4
  66.7%
22
  68.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 4 participants 6 participants 6 participants 6 participants 6 participants 32 participants
66.97  (1.37) 65.10  (9.78) 65.58  (10.00) 69.46  (8.04) 68.00  (13.13) 66.19  (8.02) 66.99  (8.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 6 participants 6 participants 6 participants 6 participants 32 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
4
 100.0%
4
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
32
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 4 participants 6 participants 6 participants 6 participants 6 participants 32 participants
4 4 6 6 6 6 32
1.Primary Outcome
Title Maximum Tolerated Dose of Samarium-153
Hide Description

To determine the maximum tolerated dose (MTD) of Samarium as adjuvant to combined hormonal therapy (HT) and external beam radiation therapy (RT).

Dose levels:

Dose I: 0.25 mCi/kg IV Dose II: 0.5 mCi/kg IV Dose III: 0.75 mCi/kg IV Dose IV: 1.0 mCi/kg IV Dose V: 1.5 mCi/kg IV Dose VI: 2.0 mCi/kg IV

Dose-limiting toxicity will be defined as Grade 3 hematologic toxicity per NCI Common Toxicity Criteria. The maximally tolerated dose (MTD) will then be the last dose studied or the previous dose, based on clinical judgment of the degree of toxicity seen at the last dose.

Time Frame 5 months (1 month HT, administration of drug, 4 months HT and RT)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Samarium-153
Hide Arm/Group Description:
Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: mCi/kg
2.0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Samarium-153 (0.25 mCi/kg) Samarium-153 (0.5 mCi/kg) Samarium-153 (0.75 mCi/kg) Samarium-153 (1.0 mCi/kg) Samarium-153 (1.5 mCi/kg) Samarium-153 (2.0 mCi/kg)
Hide Arm/Group Description Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
All-Cause Mortality
Samarium-153 (0.25 mCi/kg) Samarium-153 (0.5 mCi/kg) Samarium-153 (0.75 mCi/kg) Samarium-153 (1.0 mCi/kg) Samarium-153 (1.5 mCi/kg) Samarium-153 (2.0 mCi/kg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Samarium-153 (0.25 mCi/kg) Samarium-153 (0.5 mCi/kg) Samarium-153 (0.75 mCi/kg) Samarium-153 (1.0 mCi/kg) Samarium-153 (1.5 mCi/kg) Samarium-153 (2.0 mCi/kg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      1/4 (25.00%)      1/6 (16.67%)      2/5 (40.00%)      3/5 (60.00%)      5/6 (83.33%)    
Blood and lymphatic system disorders             
Leukopenia  0/4 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  2 0/5 (0.00%)  0 1/5 (20.00%)  1 5/6 (83.33%)  5
Hemoglobin  0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 2/5 (40.00%)  2 4/6 (66.67%)  4
Blood/bone marrow  0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 1/5 (20.00%)  1 4/6 (66.67%)  4
Platelet count decreased  0/4 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0 3/5 (60.00%)  4 5/6 (83.33%)  5
Gastrointestinal disorders             
Proctitis  0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1
Hemorrhoids  0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1
General disorders             
Libido decreased  0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1
Dehydration  0/4 (0.00%)  0 0/4 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Abdominal pain and cramping  0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/5 (20.00%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0
Hot flashes/flushes  0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1
Urinary incontinence  0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1
Renal and urinary disorders             
Urinary frequency/urgency  0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 3/6 (50.00%)  3
Urine color changed  0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders             
Dyspnea  0/4 (0.00%)  0 1/4 (25.00%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders             
Erythema multiforme  0/4 (0.00%)  0 0/4 (0.00%)  0 0/6 (0.00%)  0 1/5 (20.00%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Samarium-153 (0.25 mCi/kg) Samarium-153 (0.5 mCi/kg) Samarium-153 (0.75 mCi/kg) Samarium-153 (1.0 mCi/kg) Samarium-153 (1.5 mCi/kg) Samarium-153 (2.0 mCi/kg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/4 (0.00%)      0/6 (0.00%)      0/5 (0.00%)      0/5 (0.00%)      0/6 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Edouard Trabulsi, MD
Organization: Thomas Jefferson University
Phone: 215-955-1000
EMail: Edouard.Trabulsi@jefferson.edu
Layout table for additonal information
Responsible Party: Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
ClinicalTrials.gov Identifier: NCT00328614    
Other Study ID Numbers: 02C.172
2001-114 ( Other Identifier: CCRRC )
First Submitted: May 19, 2006
First Posted: May 22, 2006
Results First Submitted: June 24, 2013
Results First Posted: November 8, 2013
Last Update Posted: November 29, 2016