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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01655836
Recruitment Status : Active, not recruiting
First Posted : August 2, 2012
Last Update Posted : October 27, 2017
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Brief Summary:
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 or disease Intervention/treatment 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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : October 4, 2012
Actual Primary Completion Date : July 27, 2016
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Late nonhematologic toxicity profile [ Time Frame: Up to 5 years ]
  2. Acute and late hematologic toxicity profile of HDR and SBRT combination [ Time Frame: Up to 5 years ]
  3. Correlation of dosimetric parameters, including dose-volume factors for bladder and rectum, with acute toxicity [ Time Frame: Up to 5 years ]
  4. Patient-reported outcomes, assessed by EPIC and AUA symptom score [ Time Frame: Up to 5 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01655836

United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Principal Investigator: Robert Den, MD Thomas Jefferson University

Additional Information:
Ritter MA, Forman JD, and Kupelian PA. A Phase I/II trial of increasingly hypofractionated radiation therapy for prostate cancer. International Journal of Radiation Oncology Biology Physics 75, 2009.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University Identifier: NCT01655836     History of Changes
Other Study ID Numbers: 12D.210
2012-10 ( Other Identifier: CCRRC )
First Posted: August 2, 2012    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

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