Active — Not RecruitingNot Applicable

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

Germany452 participantsStarted 2015-05

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexMALE

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Inclusion criteria

✓. Patients with newly diagnosed prostate cancer which has been confirmed by histological examination (within the last 6 months prior to randomization)
✓. 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
✓. PSA ≤ 200 ng/ml at diagnosis (without ADT)
✓. Asymptomatic or mild symptomatic disease
✓. Locally resectable tumour stage
✓. ECOG Performance Score 0-1
✓. Submission of the patient's written declaration of informed consent following explanation
✓. Age ≥ 18 - ≤ 75 years

What they're measuring

Cancer specific survival

Timeframe: 10 years

Trial details

NCT IDNCT02454543

SponsorMartini-Klinik am UKE GmbH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

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