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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 (Jun 2026). This Phase 3 trial studies Hormone therapy for prostate cancer.

Phase 3RecruitingSven LöffelerNCT05448547Data as of Jun 2026Location: International · 4 countries

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

Treatments studied

Other

Hormone therapy

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)

Demographics

Ages ≥ 75
Male only

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.

Frequently asked questions

Is NCT05448547 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior radiation therapy, hormone therapy disqualifies patients from enrollment.

Is this trial open to female patients?

No. This trial enrolls male patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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