Phase 3
N=355
Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer
Prostate Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02175212 ↗Enrolled (actual)
355
Serious AEs
18.3%
Results posted
Nov 2016
Primary outcome: Primary: Biochemical Disease Free Survival: Estimated Percentage of Participants With Biochemical Disease-free Survival at 5 Years — 90; 81 percentage of patients — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Short term androgen deprivation (Drug); Long term androgen deprivation (Drug); Short term androgen deprivation (Radiation); Long term androgen deprivation (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Biochemical Disease Free Survival: Estimated Percentage of Participants With Biochemical Disease-free Survival at 5 Years |
90; 81 | 0.01 sig |
| SECONDARY Metastasis Free Survival: Estimated Percentage of Participants With Metastasis-free Survival at 5 Years |
94; 83 | 0.01 sig |
| SECONDARY Overall Survival: Estimated Percentage of Participants Alive at 5 Years |
95; 86 | 0.009 sig |
| SECONDARY Cause-specific Survival |
177; 173 | — |
| SECONDARY Late Toxicity |
11.1; 7.6; 8.2; 7.3; 17.6; 7.2 | — |
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.
Eligibility 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) 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
Data sourced from ClinicalTrials.gov (NCT02175212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.