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

NCT01655836 | Active Not Recruiting Phase 1 DMC FDA Device

• 3 other identifiers: 12D.2102012-10JT 1735
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicities (DLT) graded according to the National Cancer Institute, Common Toxicity Criteria (NCI, CTC), v 4.0

  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.

  Up to 3 months

Secondary Outcomes (4)

• Late nonhematologic toxicity profile

  Up to 5 years

• Acute and late hematologic toxicity profile of HDR and SBRT combination

  Up to 5 years

• Correlation of dosimetric parameters, including dose-volume factors for bladder and rectum, with acute toxicity

  Up to 5 years

• Patient-reported outcomes, assessed by EPIC and AUA symptom score

  Up to 5 years

Study Arms (1)

Treatment (HDR brachytherapy, SBRT)

EXPERIMENTAL

Patients undergo HDR brachytherapy on day 0 followed by SBRT on days 15-30

Radiation: Brachytherapy; Radiation: Stereotactic Body Radiation Therapy; Procedure: Quality-of-life assessment; Other: Questionnaire administration

Interventions

Brachytherapy RADIATION

Undergo high dose rate brachytherapy

Also known as: low-LET implant therapy, radiation brachytherapy, low-LET implant, internal radiotherapy, sealed source radiotherapy, curietherapy, endocurietherapy

Treatment (HDR brachytherapy, SBRT)

Stereotactic Body Radiation Therapy RADIATION

Undergo stereotactic body radiation therapy

Also known as: SBRT, stereotactic radiation therapy, stereotactic radiotherapy

Treatment (HDR brachytherapy, SBRT)

Quality-of-life assessment PROCEDURE

Ancillary studies

Treatment (HDR brachytherapy, SBRT)

Questionnaire administration OTHER

Ancillary studies

Treatment (HDR brachytherapy, SBRT)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (26)

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  BACKGROUND

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  PMID: 25819287 DERIVED

Related Links

• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy; Radiosurgery

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)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Robert Den, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 2, 2012
• Study Start: October 4, 2012
• Primary Completion: July 27, 2016
• Study Completion (Estimated): January 1, 2040
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

US (1)