Three-month neoadjuvant hormonal therapy before radical prostatectomy: a 7-year follow-up of a randomized controlled trial.
OBJECTIVE
To describe the outcome, assessed as the level of prostate specific antigen (PSA), of a mature (more than half the events recorded) prospective randomized study with a median follow-up of 82 months of neoadjuvant hormonal therapy before radical prostatectomy, as this has been suggested to decrease the rate of positive surgical margins (i.e. provide greater potential to completely excise the tumour).


METHODS
From December 1991 to March 1994, 126 patients with clinically localized prostate cancer were randomized between direct radical prostatectomy or a 3-month course of a gonadotrophin-releasing hormone analogue before surgery. The patients were followed by PSA determinations and a value of > 0.5 ng/mL used to define progression.


RESULTS
The incidence of positive surgical margins decreased from 45.5% to 23.6% (P = 0.016) with hormone treatment. Despite this there was no difference in PSA progression-free survival at the last follow-up; it was 51.5% for those undergoing radical prostatectomy only and 49.8% for those who received hormonal pretreatment (P = 0.588).


CONCLUSIONS
Three months of neoadjuvant hormonal therapy before radical prostatectomy offers no benefit to the patient and cannot be recommended for routine clinical use.
Aus
G
G
Department of Urology, Ryhov Hospital, Jönköping, Sweden. gunnar.aus@vgregion.se
Abrahamsson
P-A
PA
Ahlgren
G
G
Hugosson
J
J
Lundberg
S
S
Schain
M
M
Schelin
S
S
Pedersen
K
K
D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D011300:Preoperative Care / Q000379:methods; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000378:metabolism*; D011468:Prostatectomy / Q000379:methods*; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000601:surgery; D013997:Time Factors; D017329:Triptorelin Pamoate / Q000627:therapeutic use*
D018931:Antineoplastic Agents, Hormonal; D017329:Triptorelin Pamoate; D017430:Prostate-Specific Antigen