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OncoMatch/Clinical Trials/NCT03294889

ONE-SHOT Trial - Ultra-hypofractionated Single-dose SBRT for Prostate Cancer

Is NCT03294889 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies non-drug interventions for prostate cancer.

Phase 1/2RecruitingUniversity Hospital, GenevaNCT03294889Data as of May 2026

The main objective of the phase I/II trial is to determine the safety and efficacy of a single fraction SBRT at a dose of 19 Gy in patients with localized prostate cancer.

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Disease stage

Required: Stage CT1C, CT2A, CT2B, CT2C (UICC TNM 2009 / AJCC)

Excluded: Stage CT3A, CT3B

Grade: Gleason 3+3Gleason 3+4WHO 2016 Grade Groups 1, 2 (Gleason / WHO 2016)

Tumor clinical stage cT1c-2c, pN0 or cN0, M0, according to UICC TNM 2009; MRI staging must confirm AJCC stage T1, T2a, T2b or T2c; Gleason score at biopsy 3+3 or 3+4 (WHO 2016 Grade Groups 1, 2)

Performance status

WHO 0–1

Prior therapy

Cannot have received: androgen deprivation therapy

Androgen deprivation therapy or products known to affect PSA levels

Cannot have received: pelvic radiotherapy

Prior pelvic radiotherapy

Cannot have received: surgery for prostate cancer

Previous surgery for prostate cancer

Cannot have received: transurethral resection of the prostate (TURP)

Exception: TURP < 12 weeks before registration

Previous transurethral resection of the prostate (TURP) (< 12 weeks before registration)

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

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