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

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ClinicalTrials.gov Identifier: NCT02668718
Recruitment Status : Unknown
Verified February 2016 by Teuvo Tammela, Tampere University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 29, 2016
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
Teuvo Tammela, Tampere University Hospital

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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Radiation: Adjuvant radiotherapy Phase 3

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  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Radiation Therapy vs. Watchful Waiting in Prostate Cancer Patients With Positive Margins or Capsular Penetration After Radical Prostatectomy
Study Start Date : March 2004
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Biochemical disease-free survival [ Time Frame: Five years ]
  2. Overall survival [ Time Frame: Five years ]
  3. Cancer specific survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Local recurrence verified by needle or surgical biopsy [ Time Frame: Five years ]
  2. Adverse events [ Time Frame: Five years ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668718


Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Principal Investigator: Teuvo Tammela, M.D., Ph.D. Tampere University Hospital

Responsible Party: Teuvo Tammela, M.D., Ph.D., Professor of Surgery, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT02668718     History of Changes
Other Study ID Numbers: FP-FINROG-0301
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Teuvo Tammela, Tampere University Hospital:
radiotherapy, adjuvant
prostatectomy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases