Samarium-153 With Neoadjuvant Hormonal and Radiation Therapy for Locally Advanced Prostate Cancer
May 14, 2025 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
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
-
-
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
14 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
|
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:
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:
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:
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:
|
|
Experimental: Samarium-153 (0.5 mCi/kg)
Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
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:
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:
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:
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:
|
|
Experimental: Samarium-153 (0.75 mCi/kg)
Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
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:
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:
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:
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:
|
|
Experimental: Samarium-153 (1.0 mCi/kg)
Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
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:
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:
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:
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:
|
|
Experimental: Samarium-153 (1.5 mCi/kg)
Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
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:
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:
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:
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:
|
|
Experimental: Samarium-153 (2.0 mCi/kg)
Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
|
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:
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:
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:
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:
|
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.
Collaborators
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.
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 (Actual)
May 16, 2025
Last Update Submitted That Met QC Criteria
May 14, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Prostatic Neoplasms
- Antineoplastic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Sensory System Agents
- Analgesics, Non-Narcotic
- Analgesics
- Micronutrients
- Hormone Antagonists
- Antioxidants
- Protective Agents
- Growth Substances
- Vitamins
- Anabolic Agents
- Androgen Antagonists
- Estrogens
- Plant Growth Regulators
- Methyltestosterone
- Androgens
- Ascorbic Acid
- Goserelin
- Bicalutamide
- Estrogens, Conjugated (USP)
- Ethylene
- Samarium Sm-153 lexidronam
Other Study ID Numbers
- 02C.172
- 2001-114 (Other Identifier: CCRRC)
- JT 1013 (Other Identifier: JeffTrial Number)
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