Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate

NCT00030290 | Completed Phase 1

• 5 other identifiers: FOCUS-G000276CDR0000069126CWRU-050130IUMC-010233NCI-V01-1684
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Highly focused ultrasound energy may be able to kill cancer cells by heating the tumor without affecting the surrounding tissue. PURPOSE: Phase I trial to study the effectiveness of focused ultrasound energy in treating patients who have prostate cancer that has not spread beyond the prostate.

Conditions

Prostate Cancer

Keywords

stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer

Interventions

high-intensity focused ultrasound ablation PROCEDURE

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed organ-confined prostate cancer (clinical stage T1 or T2 only) * Pretreatment prostate weight less than 40 g * Gleason score no greater than 7 * PSA no greater than 10 ng/mL * No significant intravesical median lobe (greater than 2 cm) on ultrasound * Able to visualize prostate gland adequately on transrectal ultrasound imaging * No prostate calcification greater than 5 mm * No metastases by bone scan PATIENT CHARACTERISTICS: Age: * 40 to 80 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * No bleeding disorder as determined by abnormal PT and PTT Renal: * No active urinary tract infection * No history of urinary bladder neck contracture Other: * No prior allergy to latex * No Anesthesia Surgical Assignment category IV or greater * No interest in future fertility * No history of inflammatory bowel disease * No other concurrent major debilitating illness * No other prior or concurrent malignancy except skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy for prostate cancer Chemotherapy: * No prior chemotherapy for prostate cancer Endocrine therapy: * At least 3 months since prior hormonal therapy (including finasteride) for prostate cancer Radiotherapy: * No prior radiotherapy for prostate cancer Surgery: * No prior transurethral resection of prostate * No prior urethral stent * No prior major rectal surgery Other: * No prior cryotherapy for prostate cancer * No prior thermotherapy * No other prior therapy for prostate cancer * No concurrent warfarin or other anticoagulant

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

Sponsors & Collaborators

• Focus Surgery: lead

Study Sites (1)

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

High-Intensity Focused Ultrasound Ablation

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)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Michael O. Koch, MD

  Indiana University Melvin and Bren Simon Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 14, 2002
• First Posted: January 27, 2003
• Study Start: October 1, 2001
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: July 10, 2013

Record last verified: 2008-12

Locations

US (1)