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
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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 |
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 (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 |

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:
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:
|
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:
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:
|
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:
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:
|
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:
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:
|
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:
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:
|
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:
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:
|
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

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
United States, Pennsylvania | |
Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19107 |
Principal Investigator: | Edouard Trabulsi, MD | Thomas Jefferson University | |
Study Chair: | Richard Valicenti, MD, MA | UC Davis School of Medicine |
Responsible Party: | Sidney Kimmel Cancer Center at Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT00328614 |
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 |
Locally advanced prostate cancer positive lymph nodes |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Ascorbic Acid Goserelin Methyltestosterone Bicalutamide Samarium Sm-153 lexidronam Androgens Ethylene Estrogens, Conjugated (USP) Antineoplastic Agents, Hormonal |
Antineoplastic Agents Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Hormones Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Vitamins Micronutrients Nutrients Growth Substances Estrogens Anabolic Agents |