NCT00005939

Brief Summary

RATIONALE: Radiation therapy uses high-energy radiation to damage tumor cells. Brachytherapy uses radioactive material that is placed directly into or near the tumor. Brachytherapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of brachytherapy in treating patients who have recurrent prostate cancer that has not responded to standard therapy.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed
3.9 years until next milestone

First Posted

Study publicly available on registry

May 26, 2004

Completed
Last Updated

November 6, 2013

Status Verified

February 1, 2001

First QC Date

July 5, 2000

Last Update Submit

November 5, 2013

Conditions

Prostate Cancer

Keywords

stage I prostate cancerstage IIB prostate cancerstage IIA prostate cancerstage III prostate cancerrecurrent prostate cancer

Interventions

brachytherapyRADIATION
phosphorus P32RADIATION

Eligibility Criteria

Age21 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven locally recurrent prostate cancer that has failed conventional therapy (i.e., external beam radiotherapy, radioactive seed implants, and hormonal therapy) Must be confirmed clinically with elevated PSA and/or ultrasound Prostates between 2-5 cm in diameter (i.e., volumes of 4-65 cm3) preferred Prostates greater than 5 cm allowed, but 2 needles required for good distribution of study drug No clinical/radiographic evidence of metastatic disease No history of injury to urethra, bladder, or rectum PATIENT CHARACTERISTICS: Age: 21 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Neutrophil count at least 1,900/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL (transfusion allowed) Hepatic: Not specified Renal: Blood urea nitrogen no greater than 25 mg/dL Creatinine no greater than 1.5 mg/dL PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics Surgery: Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Center for Molecular Medicine

Garden City, New York, 11530, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

BrachytherapyPhosphorus-32

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Study Officials

  • Wayne S. Court, MD, PhD

    Center for Molecular Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2000

First Posted

May 26, 2004

Study Start

November 1, 1999

Last Updated

November 6, 2013

Record last verified: 2001-02

Locations

US(1)