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

Summary

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.

Eligibility

Inclusion Criteria:

* Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures
* Histologically confirmed adenocarcinoma of the prostate without small cell features
* Tumor clinical stage cT1c-2c, pN0 or cN0, M0, according to UICC TNM 2009
* MRI staging must confirm American Joint Committee on Cancer (AJCC) stage T1, T2a, T2b or T2c
* Gleason score at biopsy 3+3 or 3+4 (WHO 2016 Grade Groups 1, 2)
* PSA ≤15 ng/ml
* WHO performance status 0-1
* International Prostate Symptom Score ≤ 10 (alpha blockers allowed)
* MRI-based volume estimation of prostate gland ≤ 70 cc
* Patient agrees not to father a child during trial treatment and during 6 months thereafter

Exclusion Criteria:

* Tumor clinical stage cT3a-3b or T4
* Evidence of T3a, T3b or T4 disease as assessed by MRI
* Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies.
* Significant tumor on the transitional zone as assessed by MRI
* Gleason at biopsy ≥ 4+3
* Androgen deprivation therapy or products known to affect PSA levels
* Impossibility to implant Calypso beacons
* History of hematologic or primary solid tumor malignancy, unless in remission for at least 3 years from registration with the exception of curatively treated localized non-melanoma skin cancer
* Prior pelvic radiotherapy
* Previous surgery for prostate cancer
* Previous transurethral resection of the prostate (TURP) (\< 12 weeks before registration)
* Hip prosthesis
* Severe or active co-morbidity likely to impact on the advisability of SBRT
* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications

Conditions2

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