A Study of Neoadjuvant Hormone Therapy in Patient With Advanced Prostate Cancer Undergoing Radical Prostatectomy.

Summary

This is A Multi-centre, Single-arm, Prospective, Interventional Study to Assess Efficacy and Safety of Neoadjuvant Hormone Therapy using Zoladex (Goserelin) and Casodex (Bicalutamide) in Patients with Advanced Prostate Cancer Undergoing Radical Prostatectomy, to assess the efficacy by resectability rate of neoadjuvant hormone therapy (NHT) in subjects with advanced prostate cancer.

Timeline

Start

2021-01-28

Primary completion

2022-11-09

Completion

2022-11-09

Publications

• Results 1. Montironi R, Schulman CC. Pathological changes in prostate lesions after androgen manipulation. J Clin Pathol 1998; 51:5-12. 2. Witjes WP, Schulman CC, Debruyne FM. Preliminary results of a prospective randomized study comparing radical prostatectomy versus radical prostatectomy associated with neoadjuvant hormonal combination therapy in T2-3 N0 M0 prostatic carcinoma. Urology 1997;49(suppl):65-9. 3. Labrie F, Cusan L, Gomez JL, et al. Neoadjuvant hormonal therapy: the Canadian experience. Urology 1997;49(suppl):56-60. 4. Soloway MS, Sharifi F, Wajsman Z, et al. Random prospective study comparing radical prostatectomy alone versus radical prostatectomy preceded by androgen blockade in clinical stage B2 (T2bNxM0) prostate cancer. J Urol 1995; 154:424-8. 5. Hugosson J, Abrahamsson PA, Ahlgren G, et al. The risk of malignancy in the surgical margin at radical prostatectomy is reduced almost three-fold in patients given neoadjuvant hormone treatment. Eur Urol 1996; 29:413-16.

Drugs

Indications