Biomedical subjects

Leonard Gomella

Publications and source records attributed to Leonard Gomella.

4 recordsLinked to original sources

PubMed2006

Results of a phase II trial of transrectal ultrasound-guided permanent radioactive implantation of the prostate for definitive management of localized adenocarcinoma of the prostate (radiation therapy oncology group 98-05).

PURPOSE: To evaluate the effectiveness of transrectal ultrasound-guided permanent radioactive (125)I implantation of the prostate for organ-confined adenocarcinoma of the prostate compared with historical data of prostatectomy and external beam radiotherapy within a cooperative group setting. METHODS AND MATERIALS: Patients accrued to this study had histologically confirmed, locally confined, adenocarcinoma of the prostate with clinical Stage T1b, T1c, or T2a, no nodal or metastatic disease, prostate-specific antigen level of < or =10 ng/mL, and Gleason score of < or =6. All patients underwent transrectal ultrasound-guided radioactive (125)I permanent seed implantation into the prostate. The prescribed dose was 145 Gy to the prostate planning target volume. RESULTS: A total of 27 institutions accrued a total of 101 patients to this protocol, with no institution accruing >8 patients. Six patients were ineligible, leaving 95 properly entered as eligible in the study. The median follow-up was 5.3 years (range, 0.4-6.5 years). At 5 years, 5 patients had local failure, 1 had evidence of distant failure, and 6 (6%) had biochemical failure. The overall survival rate at 5 years was 96.7%. At last follow-up, no patient had died of prostate cancer or related toxicities. Eight patients had a maximal acute toxicity level of 3, and no patient had Grade 4 or 5 acute toxicity. During follow-up, 2 patients had maximal Grade 3 toxicity, both related to bladder issues, and no patient experienced Grade 4 or 5 toxicity. CONCLUSION: The results of this clinical protocol (a multi-institutional trial of brachytherapy for localized adenocarcinoma of the prostate) have demonstrated that this type of trial can be successfully completed through the Radiation Therapy Oncology Group. Biochemical disease-free survival was comparable with other brachytherapy published series and with the results after surgery and external beam radiotherapy.

Adenocarcinoma↗

PubMed2005

Laparoscopic partial nephrectomy: hand-assisted technique.

Laparoscopic partial nephrectomy (LPN) is a challenging procedure that has become more popular as techniques have evolved and made the procedure more standardized. We present our hand-assisted technique for LPN. In order to meet the challenges of larger, deeper lesions and to address complications, our technique has evolved from pure hand assistance to hand assistance with hilar clamping and hemostatic adjuncts. We discuss patient selection, preparation and access, renal exposure, preparation of hemostatic agents, resection of the mass, hemostasis, and closure. The results of 76 hand-assisted LPNs (HALPNs) are summarized. While our technique will undoubtedly continue to evolve, HALPN appears to be safe and effective for minimally invasive nephron-sparing surgery.

Fibrin Tissue Adhesive↗

PubMed2004

Laparoscopic radical prostatectomy after neoadjuvant hormonal therapy: an apparently safe and effective procedure.

OBJECTIVE: In an effort to determine the safety and efficacy of laparoscopic radical prostatectomy (LRP) in patients who have received neoadjuvant hormonal therapy (NHT), our initial series of 65 patients undergoing successful LRP was analyzed, specifically comparing 5 patients who received neoadjuvant hormonal therapy to 60 who did not. METHODS: From March 2000 to March 2002, 68 patients were scheduled for LRP. Three cases, none post-NHT, were converted to open radical retropubic prostatectomy (RRP). Clinical and pathologic data were recorded on the remaining 65 patients, 5 of who had received NHT. Forty-two bilateral and 16 unilateral nerve sparing LRP were performed in the non-NHT cohort, and 3 bilateral and 1 unilateral nerve sparing LRP in the NHT cohort. RESULTS: The mean patient age, preoperative prostate specific antigen (PSA), clinical stage, and biopsy grade were similar for the NHT and the non-NHT LRP cohorts. The mean estimated blood loss (EBL) and serum hemoglobin decrease (preoperative to postoperative day 1) were lower in the NHT cohort than the non-NHT cohort: 160 mL and 2.4 g/dL vs. 317 mL and 3.1 g/dL, respectively. The mean operative time and hospital stay were similar: 5.7 hours and 2.4 days for the NHT cohort and 5.8 hours and 2.8 days for the non-NHT cohorts. As expected, the mean prostate weight was lower for the NHT cohort: 36.8 g vs. 46.5 g. All NHT cohort tumors were pathologic stage pT2, with negative margins. Eleven (18%) of the non-NHT cohort had pathologic T3 (10 patients) or T4 (1 patient) tumors and 10 (17%) specimens had a positive surgical margin. Four of 5 (80%) NHT cohort and 21 of 25 (84%) non-NHT cohort patients are continent (no pad use) 3 to 6 months postsurgery. One NHT cohort patient (20%) and 20 (33%) non-NHT cohort patients had an elevated drain fluid creatinine 24 hours postoperatively. There were no other complications in the NHT cohort. All 5 NHT cohort patients have no evidence of recurrent disease, whereas 2 non-NHT cohort patients (3.3%) have developed PSA recurrence. No NHT patient and only 1 non-NHT patient received a blood transfusion postoperatively. CONCLUSION: LRP appears to be a safe and efficacious procedure in patients who have received NHT. Perioperative morbidity of NHT patients undergoing LRP appears equivalent to non-NHT patients, with slightly lower EBL, hemoglobin decrease, urinary extravasation, positive margin, and complication rates.

Antineoplastic Agents, Hormonal↗

PubMed2004

Chemoprevention of prostate cancer in men at high risk: rationale and design of the reduction by dutasteride of prostate cancer events (REDUCE) trial.

PURPOSE: Chemoprevention may significantly impact the natural history of prostate cancer. The most potent intraprostatic androgen, dihydrotestosterone, has a significant role in the pathophysiology of prostate cancer. It represents a biologically plausible target for chemoprevention through the inhibition of 5alpha-reductase isoenzymes. MATERIALS AND METHODS: The Reduction by Dutasteride of Prostate Cancer Events clinical trial is an international, multicenter, double-blind, placebo controlled chemoprevention study designed to determine if dutasteride 0.5 mg daily decreases the risk of biopsy detectable prostate cancer. A total of 8,000 men will be randomized to receive dutasteride or placebo for 4 years. Eligible men must be 50 to 75 years old, have a serum prostate specific antigen of 2.5 to 10 ng/ml (ages 50 to 60 years) or 3.0 to 10 ng/ml (older than 60 years). Men must have a negative 6 to 12 core biopsy within 6 months prior to enrollment. Repeat biopsies will be taken at 2 and 4 years. The rates of prostate cancer for each treatment group will be compared. Genetic and protein biomarkers of prostate cancer, and the effect of dutasteride on benign prostatic hyperplasia and prostatitis symptomatology and histopathology will also be assessed. RESULTS: Results remain to be determined. CONCLUSIONS: The study will examine the effects of the dual 5alpha-reductase inhibitor dutasteride on the natural history of prostate cancer in men at increased risk for this malignancy. It affords a unique opportunity to examine biomarkers and genetic linkage for prostate cancer, and assess a range of prostate health outcome measures.

5-alpha Reductase Inhibitors↗