Adjuvant Radiation Therapy vs. Watchful Waiting Following Radical Prostatectomy in High Risk Prostate Cancer
Prostatic Neoplasms
About this trial
This is an interventional treatment trial for Prostatic Neoplasms focused on measuring radiotherapy, adjuvant, prostatectomy
Eligibility Criteria
Inclusion Criteria:
Patients with pT3aN0M0 or pT2N0M0 prostate cancer with a positive margin, gleason score 2-10, preoperative PSA < 20 ug/l, postoperative PSA <0.5 ug/l after surgery (within 8 weeks), the WHO performance status 0-2, life expectancy at least 3 months, informed consent obtained.
Exclusion Criteria:
Other simultaneous cancer therapy including systemic endocrine therapy; more than 12 weeks has elapsed since surgery for prostate cancer; metastatic disease (N+ or M1); cancer invasion to the seminal vesicles; any other previous malignancy within the last 5 years except basalioma or squamous cell carcinoma of the skin; any contraindication to irradiation (severe locoregional infection, prior radiation therapy to the prostate/bladder); any physical or mental condition, which in the opinion of the investigator, may interfere with patient's ability to comply with scheduled visits.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Other
No Intervention
Adjuvant radiotherapy
Watchful waiting
Patients who were randomized to adjuvant radiotherapy following radical prostatectomy
Patients who were randomized to watchful waiting following radical prostatectomy