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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 Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Samarium-153 Drug: Total Androgen Suppression (TAS) with Bicalutamide Drug: Total androgen suppression (TAS) with Goserelin Acetate Device: Radiation Therapy Phase 1

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 Design
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Pilot Study of Samarium-153 Combined With Neoadjuvant Hormonal Therapy and Radiation Therapy in Men With Locally Advanced Prostate Cancer
Study Start Date : March 2003
Actual Primary Completion Date : February 2009
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Samarium-153 (0.25 mCi/kg)
Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
 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
Experimental: Samarium-153 (0.5 mCi/kg)
Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
 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
Experimental: Samarium-153 (0.75 mCi/kg)
Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
 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
Experimental: Samarium-153 (1.0 mCi/kg)
Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
 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
Experimental: Samarium-153 (1.5 mCi/kg)
Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
 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
Experimental: Samarium-153 (2.0 mCi/kg)
Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
 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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00328614


Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Cytogen Corporation
Investigators
Principal Investigator: Edouard Trabulsi, MD Thomas Jefferson University
Study Chair: Richard Valicenti, MD, MA UC Davis School of Medicine
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center  This link exits the ClinicalTrials.gov site
Thomas Jefferson University Hospitals  This link exits the ClinicalTrials.gov site

Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00328614     History of Changes
Other Study ID Numbers: 02C.172
2001-114 ( Other Identifier: CCRRC )
First Posted: May 22, 2006    Key Record Dates
Results First Posted: November 8, 2013
Last Update Posted: November 29, 2016
Last Verified: October 2016

Keywords provided by Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University ):
Locally advanced prostate cancer
positive lymph nodes

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Ascorbic Acid
Estrogens, Conjugated (USP)
Methyltestosterone
Bicalutamide
Goserelin
Samarium Sm-153 lexidronam
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins
Micronutrients
Growth Substances
Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Androgen Antagonists
Hormone Antagonists
Analgesics, Non-Narcotic