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Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

NCTNCT00328614 (opens ClinicalTrials.gov in a new tab)Other id02C.172Other id2001-114Other idJT 1013
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
32 participants (actual)
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
Mar 2003
Primary completion
Feb 2009
Completion
Jun 2011
First posted
22 May 2006 (estimated)
Last update posted
16 May 2025
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20042006200820102012
  1. Ph 1

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

    NCT00328614

    Mar 2003 to Jun 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Samarium-153Drug
  • Total Androgen Suppression (TAS) with BicalutamideDrug
  • Total androgen suppression (TAS) with Goserelin AcetateDrug
  • Radiation TherapyDevice

Arms6

  • Experimental

    Samarium-153 (0.25 mCi/kg)

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

  • Experimental

    Samarium-153 (0.5 mCi/kg)

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

  • Experimental

    Samarium-153 (0.75 mCi/kg)

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

  • Experimental

    Samarium-153 (1.0 mCi/kg)

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

  • Experimental

    Samarium-153 (1.5 mCi/kg)

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

  • Experimental

    Samarium-153 (2.0 mCi/kg)

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Maximum Tolerated Dose of Samarium-153

    Time frame · 5 months (1 month HT, administration of drug, 4 months HT and RT)

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 5 months (1 month HT, administration of drug, 4 months HT and RT)

Maximum Tolerated Dose of Samarium-153

GroupValue (mCi/kg)
Samarium-1532.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Samarium-153 (0.25 mCi/kg)Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy–0 / 40 / 4
Samarium-153 (0.5 mCi/kg)Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy–1 / 40 / 4
Samarium-153 (0.75 mCi/kg)Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy–1 / 60 / 6
Samarium-153 (1.0 mCi/kg)Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy–2 / 50 / 5
Samarium-153 (1.5 mCi/kg)Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy–3 / 50 / 5
Samarium-153 (2.0 mCi/kg)Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy–5 / 60 / 6

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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