Studienregister

Studienregister der Deutschen Gesellschaft für Urologie e.V.

g-Rampp

AcronymISRCTNEudraCTClinicaltrials.govDRKS
PV4679n.a.n.a.NCT02454543DRKS00008770

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

Status: Active (Recruitment Closed)

Purpose / Objectives

Primary Outcome

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.

Diagnosis

Prostate Cancer With Limited Bone Metastases

Patient attributes

Stage

osseous metastatic disease

Age

18-75

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 systemic therapy)
  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 with co-morbidity)
  • Detection of more than 5 bone metastases
  • Pain management with opioid analgesics
  • 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 (eg, severe bone marrow aplasia) disease
  • 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

Trial design

  • Multicenter
  • Prospective
  • Randomized
  • Two-arm
  • Open Label

Intervention

Arm 1: Radical prostatectomy and ADT

Hormone therapy plus radical prostatectomy with extended lymphadenectomy
 
vs.
 
Arm 2: Androgen deprivation therapy (ADT)
 

Documents (password protected)

Responsibilities in overall trial

Martini-Klinik am UKE Hamburg-Eppendorf

  • Tel. 040-741051313
  • Fax 040 741051323

National Coordinating Investigator

Prof. Dr. Markus Graefen

nach oben