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NCT02454543

Impact of Radical Prostatectomy as Primary Treatment in Patients With Prostate Cancer With Limited Bone Metastases

Sponsor: Martini-Klinik am UKE GmbH

View on ClinicalTrials.gov

Summary

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. Amendment05: Due to the slow tumor biology of prostate cancer, the follow-up period of 5 years is not sufficient to reach the primary endpoint of the study. For this reason, the follow-up is extended for a further 5 years with 2 visits per year.

Official title: 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

Key Details

Gender

MALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

452

Start Date

2015-05

Completion Date

2026-12-31

Last Updated

2026-01-12

Healthy Volunteers

Conditions

Prostate Cancer

Interventions

PROCEDURE

Radical prostatectomy

Study participants randomized in the intervention arm receive best systemic therapy in addition to radical prostatectomy with extended lymphadenectomy. It is not crucial whether the radical prostatectomy is performed open or robot-assisted.

DRUG

Best systemic therapy

For the antiandrogenic therapy a non-steroidal antiandrogen (e.g. flutamide, bicalutamide) or a gonadotropin-releasing hormone (GnRH) analogues (e.g. goserelin, leuprolide) are available. The selection of best systemic therapy is up to the judgment of the treating urologist.

Patients with locally resectable intermediate and high-risk prostate cancer which has been confirmed by biopsy according to D'Amico criteria (intermediate risk: PSA 10-20 ng/ml, cT2b-c, Gleason score 7; high risk: PSA \>20 ng/ml, \>cT2c, Gleason score 8-10) with clinical evidence of bone metastases in imaging tests can be included. Necessary radiotherapy of the bone metastases as required is also permitted prior to inclusion in the study. In line with the results from the recent CHAARTED and STAMPEDE studies (Sweeny et al., 2015, James et al 2015), early treatment with taxanes may be used in both the standard treatment arm as well as in the intervention arm where the prostatektomie is performed. The period 6 months from the initial diagnosis to randomization and possibly three months from randomization to surgery must be complied with. 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

Locations (1)

Markus Graefen

Hamburg, Nein, Germany