Clinical trial NCT02175212: Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Adenocarcinoma
Keywords: Patients with prostate adenocarcinoma
Lead sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 362
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)\<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

Primary outcomes:
measure: Biochemical Disease Free Survival: Estimated Percentage of Participants With Biochemical Disease-free Survival at 5 Years
timeFrame: 5 years
Secondary outcomes:
measure: Metastasis Free Survival: Estimated Percentage of Participants With Metastasis-free Survival at 5 Years
timeFrame: 5 years
measure: Overall Survival: Estimated Percentage of Participants Alive at 5 Years
timeFrame: 5 years
measure: Cause-specific Survival
timeFrame: 5 years
measure: Late Toxicity
timeFrame: 5 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
Study officials:
affiliation: Grupo de Investigación Clínica en Oncología Radioterapia
name: Almudena Zapatero, MD PhD, IP
role: PRINCIPAL_INVESTIGATOR
References:
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