Multicentric, prospective, randomized study to evaluate the effect of standard drug therapy with or without radical prostatectomy (RP) in patients with limited bone metastatic prostate cancer

Not Applicable

• Conditions: C61; Malignant neoplasm of prostate

• Registration Number: DRKS00008770
• Lead Sponsor: Martini-Klinik am UKE GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: Male
• Target Recruitment: 129

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 Status 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

1. Contraindications to radical prostatectomy (locally non-resectable disease, increased anaes-thesia risk with corresponding comorbidity)
2. Evidence of more than 5 bone metastases
3. Pain management with opioid analgesics
4. Evidence of visceral metastases or brain metastases
5. Neuroendocrine and/or small cell differentiation in the histology of the biopsy
6. Charlson Comorbidity Index > 2
7. ECOG Performance Status >1
8. Myocardial infarction or stroke within the last 6 months
9. Existing major cardiovascular (grade III - IV according to NYHA), pulmonary (pO2 <60 mmHg), renal, hepatic or haematopoietic (e.g. severe bone
marrow aplasia) disease
10. Severe psychiatric disorders in persons housed by a judicial or administrative arrangement in an institution
11. Simultaneous participation in another clinical study with interventional character of the meta-static prostate cancer

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective is the tumour-specific survival time, defined as the time from randomization until death due to the underlying prostate cancer. In the event of death due to other causes, the time up to death is assessed as a concurrent event. For patients still living at the end of the follow-up the time from the randomization up to the last contact is entered as censored observation.