Overview

This trial is active, not recruiting.

Condition prostatic neoplasms
Treatment adjuvant radiotherapy
Phase phase 3
Sponsor Helsinki University Central Hospital
Start date March 2004
End date October 2017
Trial size 250 participants
Trial identifier NCT02668718, FP-FINROG-0301

Summary

The purpose of this study is to determine whether adjuvant radiotherapy following radical prostatectomy in prostate cancer patients with positive margins or capsular penetration improves biochemical, overall and/or cancer specific survival and whether adjuvant radiotherapy is reasonably well tolerated when compared to watchful waiting.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Patients who were randomized to adjuvant radiotherapy following radical prostatectomy
adjuvant radiotherapy
The radiation therapy will be given in 37 fractions of 1.8 Gy per day, five days per week. The total dose of radiation will be 66.6 Gy.
(No Intervention)
Patients who were randomized to watchful waiting following radical prostatectomy

Primary Outcomes

Measure
Biochemical disease-free survival
time frame: Five years
Overall survival
time frame: Five years
Cancer specific survival
time frame: 5 years

Secondary Outcomes

Measure
Local recurrence verified by needle or surgical biopsy
time frame: Five years
Adverse events
time frame: Five years

Eligibility Criteria

Male participants of any age.

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.

Additional Information

Official title Adjuvant Radiation Therapy vs. Watchful Waiting in Prostate Cancer Patients With Positive Margins or Capsular Penetration After Radical Prostatectomy
Principal investigator Teuvo Tammela, M.D., Ph.D.
Description In this study the investigators will evaluate adjuvant radiation therapy vs. watchful waiting in prostate cancer patients with positive margins or capsular penetration after radical prostatectomy. This is a randomized, open label, multicentre, collaborative study of FinnProstate Group and Finnish Radiation Oncology group.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Helsinki University Central Hospital.