Three‐month neoadjuvant hormonal therapy before radical prostatectomy: a 7‐year follow‐up of a randomized controlled trial

Abstract

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). Patient and methods From December 1991 to March1994, 126 patients with clinically localized prostate cancer were randomized between direct radical prostatectomy or a 3-month course of a gonadotrophinreleasing hormone analogue before surgery. The patients were followed by PSA determinations and a value of > 0.5 ng/mL used to define progression. ResultsThe 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.

Neoadjuvant Docetaxel before Radical Prostatectomy in Patients with High-Risk Localized Prostate Cancer

“…Thus far, however, trials testing the neoadjuvant use of androgen deprivation therapy (7,8) or early chemotherapy (9) in prostate cancer have been disappointing and have failed to show compelling clinical or survival advantages. Recently, docetaxel, either alone or in combination with estramustine, has shown an excellent biochemical response rate (significant prostate-specific antigen reductions in z50% of men; ref.…”

Use of androgen deprivation therapy in prostate cancer: indications and prevalence

“…Unfortunately, these studies did not reveal an improvement in long-term outcomes such as a survival benefit. [16][17][18] Other studies have evaluated longer duration of ADT. In a large, prospective phase III trial, the ability of 3 months vs. 8 months of neoadjuvant ADT to reduce PSA recurrence rates after radical prostatectomy was examined.…”

Beyond Castration—Defining Future Directions in the Hormonal Treatment of Prostate Cancer

“…Neoadjuvant hormonal therapies have been extensively attempted in prostate cancer, without success [57,58], whilst adjuvant hormonal therapy has become a de facto standard of care for men with PSA relapse, or even high risk disease [59] albeit only with a poor evidence base [60,61]. If more profound androgen deprivation is to find a role, it is provocative to hypothesise that similar to radiation there may be a defined role in high-risk prostate cancer for adjuvant hormonal therapies.…”