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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status and phase: Completed; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: Samarium-153; Drug: Total Androgen Suppression (TAS) with Bicalutamide; Device: Radiation Therapy; Drug: Total androgen suppression (TAS) with Goserelin Acetate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00328614

JT 1013 (Other Identifier)

2001-114 (Other Identifier)

02C.172

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 6 patient groups

Samarium-153 (0.25 mCi/kg)

Experimental group

Description:

Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy

Treatment:

Drug: Total androgen suppression (TAS) with Goserelin Acetate

Device: Radiation Therapy

Drug: Total Androgen Suppression (TAS) with Bicalutamide

Drug: Samarium-153

Samarium-153 (0.5 mCi/kg)

Experimental group

Description:

Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy

Treatment:

Drug: Total androgen suppression (TAS) with Goserelin Acetate

Device: Radiation Therapy

Drug: Total Androgen Suppression (TAS) with Bicalutamide

Drug: Samarium-153

Samarium-153 (0.75 mCi/kg)

Experimental group

Description:

Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy

Treatment:

Drug: Total androgen suppression (TAS) with Goserelin Acetate

Device: Radiation Therapy

Drug: Total Androgen Suppression (TAS) with Bicalutamide

Drug: Samarium-153

Samarium-153 (1.0 mCi/kg)

Experimental group

Description:

Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy

Treatment:

Drug: Total androgen suppression (TAS) with Goserelin Acetate

Device: Radiation Therapy

Drug: Total Androgen Suppression (TAS) with Bicalutamide

Drug: Samarium-153

Samarium-153 (1.5 mCi/kg)

Experimental group

Description:

Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy

Treatment:

Drug: Total androgen suppression (TAS) with Goserelin Acetate

Device: Radiation Therapy

Drug: Total Androgen Suppression (TAS) with Bicalutamide

Drug: Samarium-153

Samarium-153 (2.0 mCi/kg)

Experimental group

Description:

Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy

Treatment:

Drug: Total androgen suppression (TAS) with Goserelin Acetate

Device: Radiation Therapy

Drug: Total Androgen Suppression (TAS) with Bicalutamide

Drug: Samarium-153