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

Launched by UNIVERSITY HOSPITAL, GENEVA · Sep 22, 2017

Keywords

ClinConnect Summary

The ONE-SHOT Trial is a clinical study looking at a new way to treat localized prostate cancer using a single high-dose radiation therapy called SBRT (Stereotactic Body Radiation Therapy). The goal is to find out if giving a one-time dose of 19 Gray (a measure of radiation) is safe and effective for men with this type of cancer. The trial is currently recruiting participants aged 65 to 74 who have been diagnosed with a specific stage of prostate cancer and meet certain health criteria.

To be eligible, participants must have a confirmed diagnosis of prostate cancer without any aggressive features and their cancer should not have spread beyond the prostate. They should also have a specific score on their biopsy and be in good overall health. Participants will receive the radiation treatment and will be monitored for safety and effectiveness. It's important to note that men in this trial will need to agree not to father a child during the treatment and for six months afterward. This trial offers a potential new treatment option for prostate cancer, and those interested should discuss it with their healthcare provider.

Gender

MALE

Eligibility criteria

• 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