Adjuvant Radiation Therapy vs. Watchful Waiting Following Radical Prostatectomy in High Risk Prostate Cancer

February 1, 2016 updated by: Teuvo Tammela, Helsinki University Central Hospital

Adjuvant Radiation Therapy vs. Watchful Waiting in Prostate Cancer Patients With Positive Margins or Capsular Penetration After Radical Prostatectomy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Adjuvant radiotherapy
Patients who were randomized to adjuvant radiotherapy following radical prostatectomy
Radiation: 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: Watchful waiting
Patients who were randomized to watchful waiting following radical prostatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Five years
Five years
Cancer specific survival
Time Frame: 5 years
5 years
Biochemical disease-free survival
Time Frame: Five years
Five years

Secondary Outcome Measures

Outcome Measure
Time Frame
Local recurrence verified by needle or surgical biopsy
Time Frame: Five years
Five years
Adverse events
Time Frame: Five years
Five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Teuvo Tammela, M.D., Ph.D., Tampere university Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Estimate)

February 2, 2016

Last Update Submitted That Met QC Criteria

February 1, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FP-FINROG-0301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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