Multicentric, Prospective, Randomized Controlled Trial Comparing Radical Prostatectomy Plus Neoadjuvant Hormones With Androgen Deprivation Therapy Alone in the Management of Men With Pauci-metastatic Prostate Cancer

Uncategorized

Multicentric, Prospective, Randomized Controlled Trial Comparing Best Systemic Therapy (BST) With Radical Prostatectomy or BST Alone in the Management of Men With Pauci-metastatic Prostate Cancer

Condition: Prostate Cancer

Intervention:

  • Procedure: Radical prostatectomy
  • Drug: Best systemic therapy

Purpose: The aim of the study is to investigate, the effect of radical prostatectomy with extended lymphadenectomy on cancer-specific survival, time to castration-resistance, time to progression and quality of life in patients with a limited bone metastatic prostate cancer. In addition the influence of patient- and disease-related factors on clinical outcome (prognostic effect) and on the comparison therapy (predictive effect) will be examined.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02454543

Sponsor: Martini-Klinik am UKE GmbH

Primary Outcome Measures:

  • Measure: Cancer specific survival
  • Time Frame: 5 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Developement of castration-resistance measured by PSA value
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Progression-free survival
  • Time Frame: 5 years
  • Safety Issue:
  • Measure: Overall survival
  • Time Frame: 5 years
  • Safety Issue:

Estimated Enrollment: 452

Study Start Date: May 2015

Eligibility:

  • Age: minimum 18 Years maximum 75 Years
  • Gender: Male

Inclusion Criteria:

  • 1. Patients with newly diagnosed prostate cancer which has been confirmed by histological examination (within the last 6 months prior to randomization) 2. At least one and at most 5 bone metastases in imaging tests (bone scintigraphy, CT, MRT or PET) at diagnosis with no evidence of visceral metastasis. Patients with evidence of lymph node metastasis (N1) are allowed 3. PSA ≤ 200 ng/ml at diagnosis (without ADT) 4. Asymptomatic or mild symptomatic disease 5. Locally resectable tumour stage 6. ECOG Performance Score 0-1 7. Submission of the patient’s written declaration of informed consent following explanation 8. Age ≥ 18
  • ≤ 75 years 9. Full legal capacity and compliance of the Patient

Exclusion Criteria:

  • Contraindications to radical prostatectomy (Local non-resectable disease, increased anesthetic risk due to comorbidities)
  • Detection of more than 5 bone metastases
  • Pain management with opioid analgetics
  • Evidence of visceral metastases or brain metastases
  • Neuroendocrine and / or small cell differentiation in histology of the biopsy
  • Charlson Comorbidity Index > 2
  • ECOG Performance Score > 1
  • Myocardial infarction or stroke within the last 6 months
  • Existing major cardiovascular (grade III
  • IV according to NYHA), pulmonary (pO2 <60 mmHg), renal, hepatic or hematopoietic disease (e.g. severe bone marrow aplasia)
  • Severe psychiatric disorders persons housed on judicial or administrative arrangement in an institution
  • Simultaneous participation in another clinical trial with interventional character of the metastatic prostate cancer

Contact:

  • Anke Renter
  • +4940741051300

Location:

  • Martini-Klinik am UKE GmbH
  • Hamburg 20246 Germany

View trial on ClinicalTrials.gov

X