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

NCT00328614 | Completed Phase 1 Results DMC

• 3 other identifiers: 02C.1722001-114JT 1013
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Locally advanced prostate cancer; positive lymph nodes

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose of Samarium-153

  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)

Study Arms (6)

Samarium-153 (0.25 mCi/kg)

EXPERIMENTAL

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

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

Samarium-153 (0.5 mCi/kg)

EXPERIMENTAL

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

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

Samarium-153 (0.75 mCi/kg)

EXPERIMENTAL

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

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

Samarium-153 (1.0 mCi/kg)

EXPERIMENTAL

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

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

Samarium-153 (1.5 mCi/kg)

EXPERIMENTAL

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

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

Samarium-153 (2.0 mCi/kg)

EXPERIMENTAL

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

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

Interventions

Samarium-153 DRUG

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).

Also known as: Samarium-153-ethylene diamine tetramethylene phosphonate, Samarium (153Sm) lexidronam, Quadramet

Samarium-153 (0.25 mCi/kg); Samarium-153 (0.5 mCi/kg); Samarium-153 (0.75 mCi/kg); Samarium-153 (1.0 mCi/kg); Samarium-153 (1.5 mCi/kg); Samarium-153 (2.0 mCi/kg)

Total Androgen Suppression (TAS) with Bicalutamide DRUG

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.

Also known as: Casodex

Samarium-153 (0.25 mCi/kg); Samarium-153 (0.5 mCi/kg); Samarium-153 (0.75 mCi/kg); Samarium-153 (1.0 mCi/kg); Samarium-153 (1.5 mCi/kg); Samarium-153 (2.0 mCi/kg)

Total androgen suppression (TAS) with Goserelin Acetate DRUG

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.

Also known as: Zoladex

Samarium-153 (0.25 mCi/kg); Samarium-153 (0.5 mCi/kg); Samarium-153 (0.75 mCi/kg); Samarium-153 (1.0 mCi/kg); Samarium-153 (1.5 mCi/kg); Samarium-153 (2.0 mCi/kg)

Radiation Therapy DEVICE

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.

Also known as: XRT, Radiotherapy

Samarium-153 (0.25 mCi/kg); Samarium-153 (0.5 mCi/kg); Samarium-153 (0.75 mCi/kg); Samarium-153 (1.0 mCi/kg); Samarium-153 (1.5 mCi/kg); Samarium-153 (2.0 mCi/kg)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• Cytogen Corporation: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center
• Thomas Jefferson University Hospitals

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Samarium-153; samarium Sm-153 lexidronam; 3,5-tetrahydroaldosterone sulfate; bicalutamide; Goserelin; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Therapeutics

Results Point of Contact

• Title: Edouard Trabulsi, MD
• Organization: Thomas Jefferson University

Edouard.Trabulsi@jefferson.edu

215-955-1000

Study Officials

• Edouard Trabulsi, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Richard Valicenti, MD, MA

  UC Davis School of Medicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2006
• First Posted: May 22, 2006
• Study Start: March 1, 2003
• Primary Completion: February 1, 2009
• Study Completion: June 1, 2011
• Last Updated: May 16, 2025
• Results First Posted: November 8, 2013

Record last verified: 2025-05

Locations

US (1)