Prostate Cancer Clinical Trial
Official title:
ONE-SHOT - Single Shot Radiotherapy for Localized Prostate Cancer. A Multicenter, Single Arm, Phase I/II Trial
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.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | October 1, 2030 |
Est. primary completion date | October 1, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 85 Years |
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital of Geneva | Genève |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Geneva | Humanitas Hospital, Italy, Kantonsspital Graubünden, University of Zurich |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical performance | Toxicity will be evaluated using Grade = 3 genitourinary and/or gastrointestinal acute adverse event (AE) during the first 3 month according to CTCAE classification v.4.03 (Phase I). | 3 months | |
Primary | Progression free survival (PFS) | The primary endpoint is 3-years biochemical relapse free survival (bRFS). bRFS and its 97.5% one-sided confidence interval (CI) will be determined using the Kaplan Meier method. If the expected value of 96% isn't included in this interval, the efficacy of the experimental treatment will be questioned. (Phase II). | 3 years |
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