Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
Brief summary
RATIONALE: High-intensity focused ultrasound energy may be able to kill tumor cells by heating them without affecting normal tissue. PURPOSE: This phase II trial is studying how well high-intensity focused ultrasound ablation therapy works in treating patients with localized prostate cancer.
Detailed description
OBJECTIVES: Primary * To determine patient acceptability, feasibility, and side-effect profile by evaluating records of adverse events. * To determine patient acceptability, feasibility, and side-effect profile by evaluating urinary symptoms and erectile function before study stage 1 (verification), before study stage 2 (treatment), and at each follow-up visit. Secondary * To determine the effectiveness of therapy by post-treatment transrectal ultrasound-guided biopsies at 6 months and if there is evidence of biochemical failure. * To determine the effectiveness of therapy by post-treatment MRI to evaluate area of necrosis and presence of any residual tissue. * To determine the effectiveness of therapy by measurement of prostate-specific antigen (PSA) at each follow-up visit and measurement of time to PSA nadir. * To determine the effectiveness of therapy by recording the need for secondary or adjuvant treatment following therapy. OUTLINE: Patients undergo hemiablation using high-intensity focused ultrasound to the side of the prostate with cancer and up to 5 mm over into the contralateral side to ensure adequacy. Patients complete questionnaires periodically during study to assess urinary symptoms and erectile dysfunction. These include the International Index of Erectile Function-15 \[IIEF-15\]; the International Prostate Symptom Score \[IPSS\] and IPSS-QoL; the Functional Assessment of Cancer Therapy - Prostate (FACT-P); and the Continence Questionnaire. After completion of study treatment, patients are followed at 2-7 days, 7-14 days, and at 1, 3, 6, 9, and 12 months.
Interventions
OTHERquestionnaire administration
PROCEDUREquality-of-life assessment
Sponsors
University College London Hospitals
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
MALE
Age
No minimum to 79 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate, meeting the following criteria: * Gleason score ≤ 7 (patterns 3+4 or 4+3 or less are acceptable) * Cancer prostate-confined only * Cancer confined to one lobe as defined by transrectal ultrasound (TRUS) biopsy * Serum prostate-specific antigen (PSA) ≤ 15 ng/mL * Prostate volume ≤ 40 cc OR AP length of prostate \< 4 cm * Unilateral prostate adenocarcinoma must be verified in stage 1 of this trial unless the patient has had multi-sequence MRI and transperineal template biopsies outside of this trial in similar procedure protocols to this trial * No evidence of metastatic disease * No intraprostatic calcifications ≥ 10 mm in size in cancer-positive side of prostate PATIENT CHARACTERISTICS: * Life expectancy ≥ 5 years * No latex allergies * No American Society of Anesthesiology surgical risk score III or IV * No contraindications to MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, or metallic implant likely to contribute significant artefact to images) * Must be fit for general anesthesia or regional anesthesia as assessed by the consultant anesthetist PRIOR CONCURRENT THERAPY: * More than 6 months since prior androgen suppression therapy * No prior radiotherapy for prostate cancer * No prior chemotherapy for prostate cancer * No prior significant rectal surgery preventing insertion of transrectal probe * No prior transurethral resection of the prostate or laser prostatectomy * No prior high-intensity focused ultrasound, cryosurgery, thermal, or microwave therapy to the prostate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Side effect profile | — |
| Feasibility | — |
| Adverse events | — |
| Patient acceptability as assessed by Assessment of Cancer Therapy - Prostate (FACT-P), International Prostate Symptom Score (IPSS) , IPSS-Quality of Life, Continence Questionnaire, and 15-Item International Index of Erectile Function | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of prostate-specific antigen (PSA) kinetics including time to PSA nadir | — |
| Exclusion of cancer on MRI at 2-7 days and at 6 months | — |
| Transrectal ultrasound biopsies at 6 months | — |
| Need for secondary or adjuvant treatment for prostate cancer following therapy | — |
Countries
United Kingdom
Outcome results
None listed