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NCT Number: NCT02175212

Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer

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.

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Key information

Conditions

Prostate Adenocarcinoma

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Short term androgen deprivation

Drug
  • 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

Other names: Neoadjuvant and concomitant

Long term androgen deprivation

Drug
  • 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
  • Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy

Other names: Neoadjuvant, concomitant and adjuvant

Short term androgen deprivation

Radiation

Minimum dose of 76 Gy (range 76-82 Gy)

Long term androgen deprivation

Radiation

Minimum dose of 76 Gy (range 76-82 Gy)

Primary outcomes

  1. Biochemical Disease Free Survival: Estimated Percentage of Participants With Biochemical Disease-free Survival at 5 Years

    Time frame: 5 years

    Biochemical relapse was defined as the time from inclusion in the study (randomization) until the patient meets criteria for Biochemical failure (Phoenix criteria: PSA nadir plus 2 ng/ml).

Secondary outcomes

  1. Metastasis Free Survival: Estimated Percentage of Participants With Metastasis-free Survival at 5 Years

    Time frame: 5 years

    Metastasis free survival: defined as the time from inclusion in the study (randomization) until the appearance of distant metastases: a positive result in any of the tests performed (scintigraphy, chest radiography, thorax, abdominal and pelvic CT and MRI).

  2. Overall Survival: Estimated Percentage of Participants Alive at 5 Years

    Time frame: 5 years

    Overall Survival: defined as the time that elapses from the patient enters the study until the patient dies from any cause.

  3. Cause-specific Survival

    Time frame: 5 years

    Cause-specific survival included all deaths from prostate cancer or treatment complications, and deaths from unknown causes in patients with either active cancer or a previously documented relapse

  4. Late Toxicity

    Time frame: 5 years

    Defined as the maximal rectal, urinary and cardiovascular (CV) toxicity per patient more than 90 days after completion of RT.

    Scoring scales used were the radiation morbidity scoring criteria of the European Organization for Research and Treatment of Cancer-Radiation Therapy Oncology Group (EORTC/RTOG) and the Common Terminology Criteria for Adverse Events (CTCAEs) v 3.0 for the remained toxicity.

    CV events were defined according to the World Health Organization criteria

Sponsors and collaborators

Lead sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Other

Registry information

Official study 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.

Acronym: AADLPC

Important dates

Study start
2005
Primary completion
2014
Study completion
2020
First posted
Jun 26, 2014
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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