Clinical trial NCT00243321: High Dose-Rate Brachytherapy and/or Intensity Modulated External Beam Radiation Therapy for Prostate Cancer
Official title: Phase I Examination of Combination High Dose-Rate Brachytherapy and/or Intensity Modulated External Beam Therapy for the Comprehensive Local Treatment of Patients With Locally Confined Adenocarcinoma of the Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenocarcinoma of the Prostate
Keywords: brachytherapy
intensity-modulated radiation therapy
prostate specific antigen
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2005-10-21
Enrollment: 27
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The principal objective of this study is to demonstrate that patients can safely receive combined High Dose Rate brachytherapy and Intensity-Modulated Radiation Therapy without experiencing a treatment limiting toxicity.

Detailed description: Patients will receive a single High Dose Rate brachytherapy dose of 6 Gy to the prostate, followed by 61 Gy delivered to the prostate and nearby tissues using Intensity-Modulated Radiation Therapy in 28 treatments.

Eligibility criteria: Inclusion Criteria:

* TRUS biopsy proven adenocarcinoma of the prostate Pretreatment PSA \<30 ng/ml Gleason's sum \< 8 clinical stage T1 or T2a,b. patients that are at low-intermediate risk for disease beyond the prostate normal liver function for all patients beginning hormone therapy Karnofsky Performance score \> 80 acceptable anesthesia risk as determined through routine pre-operative screening in the VCUHS Diagnostic Testing Clinic

Exclusion Criteria:

* pubic-arch interference or regional disease ( no evidence of metastatic disease for patients whose PSA is greater than 10 ng/ml, Gleason's sum is greater than 6, or T-stage is greater than T2a.

Patients at high risk for distant disease (PSA \> 30 ng/ml, Gleason's sum \> 8 or clinical stage \> T2c), clinically involved seminal vesicles or extension beyond the prostate capsule history of inflammatory bowel disease require steroid or cytotoxic therapy for collagen vascular disease uncontrolled or poorly controlled hypertension uncontrolled or poorly controlled diabetes mellitus history of cancer other than skin cancer within five years of the initiation of protocol treatment history of pelvic irradiation require the routine use of warfarin

Primary outcomes:
measure: To demonstrate that patients can safely receive combined HDR brachytherapy and IMRT teletherapy to a total dose consistent with current treatment policies and without experiencing a treatment limiting toxicity
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Michael P Hagan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amer AM, Mott J, Mackay RI, Williams PC, Livsey J, Logue JP, Hendry JH. Prediction of the benefits from dose-escalated hypofractionated intensity-modulated radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2003 May 1;56(1):199-207. doi: 10.1016/s0360-3016(03)00086-5.