Neoadjuvant hormone treatment with leuprolide acetate depot 3.75 mg and cyproterone acetate, before radical prostatectomy: a randomized study.
OBJECTIVE
To assess the effect of neoadjuvant hormone treatment before radical prostatectomy on: tumor/prostate volume, prostate-specific antigen (PSA) and testosterone levels, surgical margin status and tumor stage, and the ease of surgery following treatment.


METHODS
Patients with clinically localized prostatic carcinoma were randomized to receive leuprolide acetate depot 3.75 mg once a month for 3 months and cyproterone acetate 300 mg once a week for 3 weeks prior to surgery (group A). A control group of patients had surgery without any pretreatment (group B).


RESULTS
167 patients were evaluated for the efficacy parameters. In group A, 31% of patients had a reduction in tumor/prostate volume following hormone therapy. PSA and testosterone levels were significantly reduced (p = 0.0001) in patients in group A compared to basal values. Centralized histopathological data evaluated in 145 patients (group A and 75 group B) showed that more patients in group B had tumors at stages T3A and T3B than in group A; this difference was close to significance (p = 0.057). Positive surgical margins were more common in group B (60% of patients) compared to group A (39% of patients). Similarly lymph node involvement was more common in group B compared to group A (11 versus 3%). There was little difference between the 2 study groups for the other surgical parameters assessed (ease of dissection, duration of surgery, blood loss).


CONCLUSIONS
Neoadjuvant hormone therapy before radical prostatectomy has some effects in the treatment of prostate cancer. However, long-term follow-up of patients is needed to assess the impact of this therapy on morbidity and mortality.
Prezioso
Domenico
D
Urology Clinic, University Federico II, Naples, Italy. dprezioso@libero.it
Lotti
Tullio
T
Polito
Mario
M
Montironi
Rodolfo
R
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage*; D017024:Chemotherapy, Adjuvant; D017373:Cyproterone Acetate / Q000008:administration & dosage*; D003692:Delayed-Action Preparations; D006801:Humans; D016729:Leuprolide / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011300:Preoperative Care; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery
D018931:Antineoplastic Agents, Hormonal; D003692:Delayed-Action Preparations; D017373:Cyproterone Acetate; D016729:Leuprolide