Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer

NCT00005075 | Terminated Phase 3

• 3 other identifiers: CDR0000067682EDAP-G980308GUMC-99034
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Ultrasound therapy kills tumor cells by heating them to several degrees above body temperature. This treatment may be effective for prostate cancer. PURPOSE: Phase III trial to determine the effectiveness of ultrasound therapy in treating patients who have stage I or stage II prostate cancer that has recurred following radiation therapy.

Conditions

Prostate Cancer

Keywords

stage I prostate cancer; stage II prostate cancer; recurrent prostate cancer

Interventions

high-intensity focused ultrasound ablation PROCEDURE

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically proven stage I or II prostate cancer Organ confined (T1 or T2) At least 1 current positive biopsy Failed prior external beam radiotherapy for T1-T2 prostate cancer within last 18 months (with no worsening of the cancer in the first 12 months after radiotherapy) PSA nadir less than 4 ng/mL after external beam radiotherapy If prior hormonal therapy, PSA must be greater than 1.0 ng/mL and testosterone level normal after therapy Prostate volume no greater than 35 g, or 35-50 g if maximum anterior posterior diameter no greater than 2.5 cm Kattan Nomogram at least .50 60-month recurrence-free probability prior to external beam radiotherapy ASA Classification 1-3 No lymph node involvement by CT scan No metastases No prostate seroma, prostate abscess, or active prostatitis Must meet the following conditions: No artificial sphincter, penile prosthesis, or intraprostatic implant such as stent or catheter Normal rectal anatomy and rectal mucosa Rectal wall measurement no greater than 6 mm with treatment probe in place No calcification inducing a shadow in the prostate that would preclude study No significant rectal or bladder morbidity after radiotherapy (RTOG/EORTC rectal or bladder scores at least 2) No rectal fibrosis, stenosis, fistula, disease, or other rectal anomalies that would make rectal probe insertion difficult PATIENT CHARACTERISTICS: Age: 50 and over Performance status: Not specified Life expectancy: At least 5 years Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine greater than 1.8 mg/dL No prior superficial bladder cancer, urethral stricture, or bladder neck contracture No active urinary tract infection No upper urinary tract disease No compromised renal function No urinary tract fistula No urethral stenosis Other: No inflammatory bowel disease No interest in future fertility No prior HIV infection, AIDS, or other immunosuppression No known latex hypersensitivity Mentally coherent and capable of completing symptom and quality of life questionnaires No prior or concurrent illness or surgery that would preclude study or follow-up PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics At least 6 months since prior hormonal therapy Radiotherapy: See Disease Characteristics No more than 10 permanent radioactive seed implants Less than 1 cm from prostate apex or less than 1.2 cm from rectal wall Surgery: At least 6 weeks since prior transurethral resection of the prostate or other prostate surgery No prior rectal surgery except hemorrhoidectomy Other: No definitive local treatment for prostate cancer since completion of external beam radiotherapy At least 2 months since prior finasteride or other agents that affect PSA (e.g., saw palmetto) At least 3 months since prior benign prostatic hypertrophy thermotherapy or hyperthermia treatment At least 30 days since prior investigational drug or device No concurrent participation in another clinical trial

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

Sponsors & Collaborators

• EDAP Technomed: lead

Study Sites (2)

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, 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

• Suzanne Courtney, MD

  EDAP Technomed

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 6, 2000
• First Posted: February 25, 2004
• Study Start: July 1, 1999
• Last Updated: November 6, 2013

Record last verified: 2009-05

Locations

US (2)