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

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.
 
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 )

Tracking Information
First Submitted Date  ICMJE May 19, 2006
First Posted Date  ICMJE May 22, 2006
Results First Submitted Date  ICMJE June 24, 2013
Results First Posted Date  ICMJE November 8, 2013
Last Update Posted Date November 29, 2016
Study Start Date  ICMJE March 2003
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2013)
Maximum Tolerated Dose of Samarium-153 [ Time Frame: 5 months (1 month HT, administration of drug, 4 months HT and RT) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 19, 2006)
Disease-free survival
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2006)
  • • Acute and late toxicity
  • Biochemical control (PSA failure)
  • Local progression
  • Distant metastasis
  • Change in bone-epithelial markers
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Samarium-153 With Neoadjuvant Hormonal and Radiation Therapy for Locally Advanced Prostate Cancer
Official Title  ICMJE A Phase I Pilot Study of Samarium-153 Combined With Neoadjuvant Hormonal Therapy and Radiation Therapy in Men With Locally Advanced Prostate Cancer
Brief Summary The purpose of this study is to determine the safety and effectiveness of Samarium-153 when given in combination with hormonal and external beam radiation therapy in men with high risk prostate cancer.
Detailed Description

The likelihood of prostate cancer cells metastasizing to bone has an early and important influence on the natural history of prostate cancer. Bone-targeted therapy, when given sequentially with hormonal therapy (androgen suppression) and radiation therapy, prolongs the progression of the disease in clinically non-metastatic prostate cancer patients.

The use of Samarium-153 EDTMP in conjunction with hormonal therapy and external beam radiation therapy has never been previously evaluated in high risk clinically localized prostate cancer. Many patients with high-risk prostate cancer develop progressive disease within 2 years of therapy indicating that subclinical metastatic disease may be present at the time of initial diagnosis. In these high-risk patients, there may be a therapeutic benefit of combining hormonal therapy with external beam radiation therapy and Samarium-153 EDTMP to treat localized and subclinical bony disease, respectively.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Samarium-153
    Samarium-153 will be administered as a single dose after one month of hormonal therapy. The dose level of Samarium-153 may change to determine maximum tolerated dose (MTD).
    Other Names:
    • Samarium-153-ethylene diamine tetramethylene phosphonate
    • Samarium (153Sm) lexidronam
    • Quadramet
  • Drug: Total Androgen Suppression (TAS) with Bicalutamide
    Patients will receive 5 months of total androgen suppression (TAS) consisting of Zoladex and Casodex. Total androgen suppression will begin 3 months prior to initiation of irradiation.
    Other Name: Casodex
  • Drug: Total androgen suppression (TAS) with Goserelin Acetate
    Patients will receive 5 months of total androgen suppression (TAS) consisting of Zoladex and Casodex. Total androgen suppression will begin 3 months prior to initiation of irradiation.
    Other Name: Zoladex
  • Device: Radiation Therapy
    Radiation therapy will begin 3 months following the initiation of hormone administration. Daily tumor doses will be given 5 days per week for 7-8 weeks.
    Other Names:
    • XRT
    • Radiotherapy
Study Arms  ICMJE
  • Experimental: Samarium-153 (0.25 mCi/kg)
    Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
    Interventions:
    • Drug: Samarium-153
    • Drug: Total Androgen Suppression (TAS) with Bicalutamide
    • Drug: Total androgen suppression (TAS) with Goserelin Acetate
    • Device: Radiation Therapy
  • Experimental: Samarium-153 (0.5 mCi/kg)
    Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
    Interventions:
    • Drug: Samarium-153
    • Drug: Total Androgen Suppression (TAS) with Bicalutamide
    • Drug: Total androgen suppression (TAS) with Goserelin Acetate
    • Device: Radiation Therapy
  • Experimental: Samarium-153 (0.75 mCi/kg)
    Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
    Interventions:
    • Drug: Samarium-153
    • Drug: Total Androgen Suppression (TAS) with Bicalutamide
    • Drug: Total androgen suppression (TAS) with Goserelin Acetate
    • Device: Radiation Therapy
  • Experimental: Samarium-153 (1.0 mCi/kg)
    Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
    Interventions:
    • Drug: Samarium-153
    • Drug: Total Androgen Suppression (TAS) with Bicalutamide
    • Drug: Total androgen suppression (TAS) with Goserelin Acetate
    • Device: Radiation Therapy
  • Experimental: Samarium-153 (1.5 mCi/kg)
    Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
    Interventions:
    • Drug: Samarium-153
    • Drug: Total Androgen Suppression (TAS) with Bicalutamide
    • Drug: Total androgen suppression (TAS) with Goserelin Acetate
    • Device: Radiation Therapy
  • Experimental: Samarium-153 (2.0 mCi/kg)
    Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
    Interventions:
    • Drug: Samarium-153
    • Drug: Total Androgen Suppression (TAS) with Bicalutamide
    • Drug: Total androgen suppression (TAS) with Goserelin Acetate
    • Device: Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 18, 2010)
32
Original Enrollment  ICMJE
 (submitted: May 19, 2006)
30
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • PSA 20-150 and Gleason score greater than or equal to 7 or clinical stage greater than or equal to T2, Gleason greater than or equal to 8, PSA less than or equal to 150
  • Pathologically positive lymph nodes
  • Pretreatment must be prior to study entry and prior to any hormonal therapy
  • Zubrod 0-1
  • Adequate hematologic function

Exclusion Criteria:

  • Patients with PSA equal to or greater than 150
  • Neuroendocrine features on histologic examination
  • Radiologic evidence of metastatic disease
  • Previous malignancy within last 5 years
  • Prior pelvic radiation therapy or orchiectomy
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00328614
Other Study ID Numbers  ICMJE 02C.172
2001-114 ( Other Identifier: CCRRC )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
Study Sponsor  ICMJE Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators  ICMJE Cytogen Corporation
Investigators  ICMJE
Principal Investigator: Edouard Trabulsi, MD Thomas Jefferson University
Study Chair: Richard Valicenti, MD, MA UC Davis School of Medicine
PRS Account Thomas Jefferson University
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP