3-month formulation of goserelin acetate ('Zoladex' 10.8-mg depot) in advanced prostate cancer: results from an Italian, open, multicenter trial.
OBJECTIVE
To determine the endocrine effects, efficacy and tolerability of the 3-month formulation of goserelin acetate ('Zoladex' 10.8-mg depot; 'Zoladex' is a trade mark of the AstraZeneca group of companies) in the treatment of patients with advanced prostate cancer.


METHODS
Between February 1996 and October 1997, this open, multicentre study enrolled 120 patients with locally advanced (T3/4) or metastatic (N+ or M1) disease, or an increase in prostate-specific antigen (PSA) level after radical prostatectomy. Patients received goserelin acetate 10.8-mg depot every 12 weeks until clinical progression or interruption for adverse events or other reasons.


RESULTS
The mean testosterone concentrations were suppressed to the castration range (< or =2 nmol/l) after 4 weeks of treatment and remained suppressed throughout the study. In total, 99/115 (86%) patients had a serum PSA response, and the mean PSA value decreased significantly during treatment (p = 0.006). The mean PSA level at baseline was significantly lower in patients without disease progression compared to those who experienced disease progression (p = 0.0002). Goserelin acetate 10.8-mg depot was well tolerated and there were no injection site reactions.


CONCLUSIONS
The goserelin acetate 10.8-mg depot is well tolerated with no injection site reactions. It produces PSA responses and provides reliable suppression of serum testosterone.
Fontana
D
D
Dipartimento di Scienze Cliniche e Biologiche Università di Torino, Divisione Universitaria di Urologia, Azienda Ospedaliera San Luigi, Orbassano, Italia.
Mari
M
M
Martinelli
A
A
Boccafoschi
C
C
Magno
C
C
Turriziani
M
M
Maymone
S S
SS
Cunico
S Cosciani
SC
Zanollo
A
A
Montagna
G
G
Frongia
M
M
Jacobellis
U
U
D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations; D017273:Goserelin / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000097:blood; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000601:surgery; D013739:Testosterone / Q000097:blood
D018931:Antineoplastic Agents, Hormonal; D003692:Delayed-Action Preparations; D017273:Goserelin; D013739:Testosterone; D017430:Prostate-Specific Antigen