Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer

Phase III Multicenter Randomized Trial of Adjuvant Androgen Deprivation in Combination With Three-dimensional Conformal Radiotherapy Doses in High and Intermediate Risk Localized Prostate Cancer.

The present study is a phase III randomized and multicentric trial evaluating the potential additional impact effect of two years adjuvant androgen deprivation when combined with neoadjuvant (4 months) and high-dose (76 Gy) conformal radiotherapy in moderate high-risk prostate cancer patients. Stratification will be performed by prognostic factors and by participating institution.

Inclusion Criteria:

• Histological proven adenocarcinoma of the prostate
• Stage: cT1c-3b N0M0 according to American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM)
• Prostatic Specific Antigen (PSA)<100 ng/ml
• Intermediate (T1-T2 with Gleason Score [GS] 7 and/or PSA 10-20)
• High risk (T3 and/or GS 8-10 and/or PSA > 20)
• Karnofsky Index (KI) performance status ≥70%
• Written informed consent

Exclusion Criteria:

• T4 N1 M1,
• Previous surgical treatment (prostatectomy or cryosurgery)
• Neoadjuvant hormonal treatment > 3 months.
• History of pelvic radiotherapy (RT)
• Contraindications for radiotherapy
• Concomitant use of chemotherapy
• Serious psychiatric or medical condition
• Current synchronic malignancies