High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Thomas Jefferson University
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01655836
First received: July 31, 2012
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

The first technology is called high dose rate brachytherapy. Brachytherapy is sometimes called internal radiation therapy. High dose rate brachytherapy is a procedure that involves temporarily placing radioactive material inside the patient's body for about 10-20 minutes. Then, the remainder of the radiation treatment will be given over a 3 week period using stereotactic body radiation therapy (SBRT). SBRT is a novel treatment modality that involves the delivery of very high individual doses of radiation to tumors with high precision. This allows the doctor to deliver the same amount of radiation in a much shorter time. The purpose of this study is to determine the safety of brachytherapy when combined with hypofractionated SBRT.


Condition Intervention Phase
Prostate Cancer
Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Radiation: Brachytherapy
Radiation: Stereotactic Body Radiation Therapy
Procedure: Quality-of-life assessment
Other: Questionnaire administration
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of High Dose Rate Brachytherapy Combined With Stereotactic Body Radiation Therapy for Intermediate Risk Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Dose limiting toxicities (DLT) graded according to the National Cancer Institute, Common Toxicity Criteria (NCI, CTC), v 4.0 [ Time Frame: Up to 3 months ] [ Designated as safety issue: Yes ]
    Data analysis of phase I studies is descriptive. All estimates of dose-specific rates (e.g., response and toxicity) will be presented with corresponding confidence intervals using the exact method.


Secondary Outcome Measures:
  • Late nonhematologic toxicity profile [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Acute and late hematologic toxicity profile of HDR and SBRT combination [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Correlation of dosimetric parameters, including dose-volume factors for bladder and rectum, with acute toxicity [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Patient-reported outcomes, assessed by EPIC and AUA symptom score [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: October 2012
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (HDR brachytherapy, SBRT)
Patients undergo HDR brachytherapy on day 0 followed by SBRT on days 15-30
Radiation: Brachytherapy
Undergo high dose rate brachytherapy
Other Names:
  • low-LET implant therapy
  • radiation brachytherapy
  • low-LET implant
  • internal radiotherapy
  • sealed source radiotherapy
  • curietherapy
  • endocurietherapy
Radiation: Stereotactic Body Radiation Therapy
Undergo stereotactic body radiation therapy
Other Names:
  • SBRT
  • stereotactic radiation therapy
  • stereotactic radiotherapy
Procedure: Quality-of-life assessment
Ancillary studies
Other: Questionnaire administration
Ancillary studies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adenocarcinoma of the prostate with intermediate risk disease T2b-T2c or Gleason score 7 or prostate specific antigen (PSA) 10-20 ng/ml, without metastatic disease
  • To rule out metastatic disease, patients must have the following tests:

    • Bone scan within 60 days prior to registration
    • Computed tomography (CT) of abdomen/pelvis within 60 days prior to registration
  • Karnofsky performance status > 70
  • Age > 18
  • PSA blood test within 60 days prior to registration
  • Prostate biopsy within 180 days prior to registration
  • Within 60 days prior to registration, hematologic minimal values:

    • Absolute neutrophil count > 1,500/mm^3
    • Hemoglobin > 8.0 g/dl
    • Platelet count > 100,000/mm^3
  • Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
  • No history of previous pelvic irradiation

Exclusion Criteria:

  • History of urological surgery or procedures predisposing to GU complications after radiation, i.e., anastomoses, stricture repair, etc. (will be determined by radiation oncologist)
  • History of prior pelvic irradiation
  • Documented distant metastatic disease
  • Prior radical prostatectomy or cryosurgery for prostate cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655836

Contacts
Contact: Robert Den, MD Robert.Den@jeffersonhospital.org
Contact: Radiation Oncology Clinical Research

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Robert Den, MD       Robert.Den@jeffersonhospital.org   
Contact: Radiation Oncology Clinical Research         
Sub-Investigator: Adam Dicker, MD, PhD         
Sub-Investigator: Maria Werner-Wasik, MD         
Sub-Investigator: Pramila Rani Anne, MD         
Sub-Investigator: Voichita Bar Ad, MD         
Sub-Investigator: Wenyin Shi, MD, PhD         
Sub-Investigator: Leonard Gomella, MD         
Sub-Investigator: Edouard Trabulsi, MD         
Sub-Investigator: Costas Lallas, MD         
Sub-Investigator: William Kevin Kelly, DO         
Sub-Investigator: Jean Hoffman-Censits, MD         
Sub-Investigator: Jianqing Lin, MD         
Sub-Investigator: Mark Hurwitz, MD         
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Robert Den, MD Thomas Jefferson University
  More Information

Additional Information:
Publications:

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01655836     History of Changes
Other Study ID Numbers: 12D.210, 2012-10
Study First Received: July 31, 2012
Last Updated: May 2, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 20, 2014