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OncoMatch/Clinical Trials/NCT05448547

Immediate Curative vs Conservative Treatment in Older Men With M0, High-risk Prostate Cancer

Is NCT05448547 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Hormone therapy for prostate cancer.

Phase 3RecruitingSven LöffelerNCT05448547Data as of May 2026

Treatment: Hormone therapyIt is currently unclear if immediate curative treatment (radiotherapy or surgery) of high-risk prostate cancer without metastasis in older men (\>=75 years) generates the same survival benefits as in younger patients or if the harms/ side-effects of immediate curative treatment outweigh the benefits. In this study the investigators randomize older patients with high-risk, non-metastatic high-risk prostate cancer to either immediate curative therapy or to conservative, more problem-oriented therapy to investigate if immediate curative treatment prolongs life, improves quality of life and is cost-effective.

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Disease stage

Grade: Gleason 8Gleason 9Gleason 10ISUP group 4ISUP group 5 (Gleason, ISUP)

Gleason grade 8-10 (ISUP group 4 and 5) other than microscopic, low-volume disease (tumor must be either palpable or visible on MRI, i.e., PIRADS 4 or 5); Locally advanced PCa (T3 or T4)

Prior therapy

Cannot have received: radiation therapy

Prior radiation to the pelvis

Cannot have received: hormone therapy

Exception: hormone therapy >3 months prior to randomization

Hormone therapy >3 months prior to randomization

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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