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CLINICAL TRIAL
JOURNAL ARTICLE
Androgen deprivation prior to radical prostatectomy for T2b and T3 prostate cancer.
Urology 1994 Februrary
OBJECTIVE: In an effort to improve on the results of radical prostatectomy for clinical stages T2b and T3 prostate cancer, a selected group of patients received androgen deprivation for three to sixteen months prior to surgery.
METHODS: Fifteen men with clinical T2b and 22 with small T3 tumors received a luteinizing hormone-releasing hormone analog (n = 34) or a bilateral orchiectomy (n = 3) three to sixteen months prior to radical retropubic prostatectomy. The prostate was evaluated with particular attention to tumor grade, presence of extracapsular extension, tumor at the inked margin, seminal vesicle invasion, and tumor in the lymph nodes.
RESULTS: No patient had clinical or chemical (prostate-specific antigen [PSA]) progression during androgen deprivation. The PSA level declined a mean 90 percent and remained above 4 ng/mL in only two patients. The prostate volume decreased an estimated 30-50 percent. Prostate cancer at the inked margin was found in 15 (41%) and seminal vesicle involvement in 11 (30%) patients. Five (14%) had tumor in regional lymph nodes. There was no difference in regard to positive margins or lymph node metastases between those clinically staged as T2b and those preoperatively staged as T3. Fourteen patients have received adjuvant therapy (13 androgen deprivation, one radiation therapy). None has progressed (mean follow-up, 38.4 months). Of 23 who did not receive immediate additional therapy, six (26%) had progression, as was evident from an increase in PSA and have since been treated. Only one continued to progress. Thirty-five of the 37 patients are alive. Seventeen (46%) are tumor free (PSA < 0.4 ng/mL) without further androgen deprivation.
CONCLUSIONS: Only a prospective randomized trial can determine whether androgen deprivation prior to radical prostatectomy has a role. The results from this trial are encouraging for several reasons. The prostate is much smaller as a result of androgen deprivation and this may facilitate surgery. Although the great majority of these patients were expected to be margin positive, 60 percent had negative margins and only 14 percent had positive lymph nodes.
METHODS: Fifteen men with clinical T2b and 22 with small T3 tumors received a luteinizing hormone-releasing hormone analog (n = 34) or a bilateral orchiectomy (n = 3) three to sixteen months prior to radical retropubic prostatectomy. The prostate was evaluated with particular attention to tumor grade, presence of extracapsular extension, tumor at the inked margin, seminal vesicle invasion, and tumor in the lymph nodes.
RESULTS: No patient had clinical or chemical (prostate-specific antigen [PSA]) progression during androgen deprivation. The PSA level declined a mean 90 percent and remained above 4 ng/mL in only two patients. The prostate volume decreased an estimated 30-50 percent. Prostate cancer at the inked margin was found in 15 (41%) and seminal vesicle involvement in 11 (30%) patients. Five (14%) had tumor in regional lymph nodes. There was no difference in regard to positive margins or lymph node metastases between those clinically staged as T2b and those preoperatively staged as T3. Fourteen patients have received adjuvant therapy (13 androgen deprivation, one radiation therapy). None has progressed (mean follow-up, 38.4 months). Of 23 who did not receive immediate additional therapy, six (26%) had progression, as was evident from an increase in PSA and have since been treated. Only one continued to progress. Thirty-five of the 37 patients are alive. Seventeen (46%) are tumor free (PSA < 0.4 ng/mL) without further androgen deprivation.
CONCLUSIONS: Only a prospective randomized trial can determine whether androgen deprivation prior to radical prostatectomy has a role. The results from this trial are encouraging for several reasons. The prostate is much smaller as a result of androgen deprivation and this may facilitate surgery. Although the great majority of these patients were expected to be margin positive, 60 percent had negative margins and only 14 percent had positive lymph nodes.
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