Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer (AADLPC)

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Status and phase: Completed; Phase 3

Conditions: Prostate Adenocarcinoma

Treatments: Radiation: Long term androgen deprivation; Radiation: Short term androgen deprivation

Study type: Interventional

Funder types: Other

Identifiers

NCT02175212

DART01/05

Details and patient eligibility

About

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.

Enrollment: 362 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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362 participants in 2 patient groups

Long term androgen deprivation

Experimental group

Description:

* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months) * Bicalutamide 50 mg tablet every day for 2 months * High dose conformal radiotherapy * Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy

Treatment:

Radiation: Long term androgen deprivation

Radiation: Long term androgen deprivation

Short term androgen deprivation

Active Comparator group

Description:

* Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months) * Bicalutamide 50 mg tablet every day for 2 months * High dose conformal radiotherapy

Treatment:

Radiation: Short term androgen deprivation

Radiation: Short term androgen deprivation