Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer

• Status: Completed
• Trial end date: 2020-09-24
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
• Treatments: Androgens; Ascorbic Acid; Bicalutamide; Estrogens, Conjugated (USP); Methyltestosterone

Criteria

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