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

November 28, 2023 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University

A Phase I Pilot Study of Samarium-153 Combined With Neoadjuvant Hormonal Therapy and Radiation Therapy in Men With Locally Advanced Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Quadramet
  • Samarium-153-ethylene diamine tetramethylene phosphonate
  • Samarium (153Sm) lexidronam
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 Names:
  • 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 Names:
  • 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:
  • Radiotherapy
  • XRT
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:
  • Quadramet
  • Samarium-153-ethylene diamine tetramethylene phosphonate
  • Samarium (153Sm) lexidronam
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 Names:
  • 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 Names:
  • 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:
  • Radiotherapy
  • XRT
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:
  • Quadramet
  • Samarium-153-ethylene diamine tetramethylene phosphonate
  • Samarium (153Sm) lexidronam
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 Names:
  • 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 Names:
  • 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:
  • Radiotherapy
  • XRT
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:
  • Quadramet
  • Samarium-153-ethylene diamine tetramethylene phosphonate
  • Samarium (153Sm) lexidronam
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 Names:
  • 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 Names:
  • 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:
  • Radiotherapy
  • XRT
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:
  • Quadramet
  • Samarium-153-ethylene diamine tetramethylene phosphonate
  • Samarium (153Sm) lexidronam
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 Names:
  • 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 Names:
  • 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:
  • Radiotherapy
  • XRT
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:
  • Quadramet
  • Samarium-153-ethylene diamine tetramethylene phosphonate
  • Samarium (153Sm) lexidronam
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 Names:
  • 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 Names:
  • 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:
  • Radiotherapy
  • XRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 months (1 month HT, administration of drug, 4 months HT and RT)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

Cytogen Corporation

Investigators

  • Principal Investigator: Edouard Trabulsi, MD, Thomas Jefferson University
  • Study Chair: Richard Valicenti, MD, MA, UC Davis School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

May 19, 2006

First Submitted That Met QC Criteria

May 19, 2006

First Posted (Estimated)

May 22, 2006

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02C.172
  • 2001-114 (Other Identifier: CCRRC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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