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

Primary Purpose

Prostatic Neoplasms

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Adjuvant radiotherapy

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring radiotherapy, adjuvant, prostatectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Arm Type

Other

No Intervention

Arm Label

Adjuvant radiotherapy

Watchful waiting

Arm Description

Patients who were randomized to adjuvant radiotherapy following radical prostatectomy

Patients who were randomized to watchful waiting following radical prostatectomy

Outcomes

Primary Outcome Measures

Biochemical disease-free survival

Overall survival

Cancer specific survival

Secondary Outcome Measures

Local recurrence verified by needle or surgical biopsy

Adverse events

Full Information

NCT ID

NCT02668718

First Posted

January 27, 2016

Last Updated

February 1, 2016

Sponsor

Helsinki University Central Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02668718

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Unknown status

Study Start Date

March 2004 (undefined)

Primary Completion Date

October 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Neoplasms

Keywords

radiotherapy, adjuvant, prostatectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adjuvant radiotherapy

Arm Type

Other

Arm Description

Patients who were randomized to adjuvant radiotherapy following radical prostatectomy

Arm Title

Watchful waiting

Arm Type

No Intervention

Arm Description

Patients who were randomized to watchful waiting following radical prostatectomy

Intervention Type

Radiation

Intervention Name(s)

Adjuvant radiotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Biochemical disease-free survival

Time Frame

Five years

Title

Overall survival

Time Frame

Five years

Title

Cancer specific survival

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Local recurrence verified by needle or surgical biopsy

Time Frame

Five years

Title

Adverse events

Time Frame

Five years

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teuvo Tammela, M.D., Ph.D.

Organizational Affiliation

Tampere University Hospital

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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