Phase II trial of bicalutamide in patients with advanced prostate cancer in whom conventional hormonal therapy failed: a Southwest Oncology Group study (SWOG 9235)

Urology. 2001 Jul;58(1):53-8. doi: 10.1016/s0090-4295(01)01010-x.


Objectives: To determine the efficacy and tolerability of bicalutamide in patients with advanced prostate cancer with progression after conventional hormonal therapy.

Methods: Fifty-two patients received bicalutamide, 150 mg once daily, as second-line therapy after progressing following treatment with orchiectomy or luteinizing hormone-releasing hormone analogue or diethylstilbestrol, alone or in combination. Patients had measurable (n = 8) or assessable (n = 44) disease, a Southwest Oncology Group performance status of 0 to 2, and no prior antiandrogen therapy or chemotherapy. The objective response to treatment was assessed every 12 weeks; symptoms and pain were assessed monthly with questionnaires for 6 months.

Results: There was evidence of palliation with three measures of pain and, to a lesser extent, with a measure of overall symptom status after 3 months of taking bicalutamide. No complete or partial responses occurred. However, 9 (20%) of 44 subjects with adequate prostate-specific antigen data had a 50% or higher decrease in their prostate-specific antigen levels, which did not correlate with symptom improvement. The median survival time was 15 months. The most common side effects were hot flashes (23%) and nausea (21%).

Conclusions: These data suggest that bicalutamide decreases pain and improves symptom status in patients with prostate cancer in whom first-line hormonal therapy failed.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Aged
  • Aged, 80 and over
  • Androgen Antagonists / therapeutic use*
  • Anilides / adverse effects
  • Anilides / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Combined Modality Therapy
  • Diethylstilbestrol / administration & dosage
  • Disease Progression
  • Humans
  • Male
  • Middle Aged
  • Nitriles
  • Orchiectomy
  • Pain / drug therapy*
  • Pain / etiology
  • Pain Measurement
  • Palliative Care
  • Prostate-Specific Antigen / analysis
  • Prostatic Neoplasms / complications*
  • Prostatic Neoplasms / drug therapy*
  • Quality of Life
  • Tosyl Compounds
  • Treatment Outcome


  • Androgen Antagonists
  • Anilides
  • Nitriles
  • Tosyl Compounds
  • Diethylstilbestrol
  • bicalutamide
  • Prostate-Specific Antigen