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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 (Jun 2026). This Phase 1/2 trial studies non-drug interventions for prostate cancer.

Phase 1/2RecruitingUniversity Hospital, GenevaNCT03294889Data as of Jun 2026Location: Switzerland

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

Demographics

Ages ≤ 85
Male only

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.

Frequently asked questions

Is NCT03294889 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior androgen deprivation therapy, pelvic radiotherapy, surgery for prostate cancer disqualifies patients from enrollment.

What disease stage is eligible?

Stage CT1C or CT2A or CT2B or CT2C is required.

Is there an age limit?

Yes. Patients must be 85 years or younger.

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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