Phase 3
Completed N=355
Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer
Source: ClinicalTrials.gov NCT02175212 ↗Enrolled (actual)
355
Serious AEs
18.3%
Results posted
Nov 2016
Primary outcomePrimary: Biochemical Disease Free Survival: Estimated Percentage of Participants With Biochemical Disease-free Survival at 5 Years — 90; 81 percentage of patients — p=0.01
◆ Published Evidence
Highly cited
301citations · ~14 / year
Risk-adapted androgen deprivation and escalated three-dimensional conformal radiotherapy for prostate cancer: Does radiation dose influence outcome of patients treated with adjuvant androgen deprivation? A GICOR study.
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.
Linked Publications (4)
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Risk-adapted androgen deprivation and escalated three-dimensional conformal radiotherapy for prostate cancer: Does radiation dose influence outcome of patients treated with adjuvant androgen deprivation? A GICOR study.
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High-dose radiotherapy with short-term or long-term androgen deprivation in localised prostate cancer (DART01/05 GICOR): a randomised, controlled, phase 3 trial.
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High-dose radiotherapy and risk-adapted androgen deprivation in localised prostate cancer (DART 01/05): 10-year results of a phase 3 randomised, controlled trial.
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Late Radiation and Cardiovascular Adverse Effects After Androgen Deprivation and High-Dose Radiation Therapy in Prostate Cancer: Results From the DART 01/05 Randomized Phase 3 Trial.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.