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

Arm | Intervention/treatment |
---|---|
Adjuvant radiotherapy
Patients who were randomized to adjuvant radiotherapy following radical prostatectomy
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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
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- Biochemical disease-free survival [ Time Frame: Five years ]
- Overall survival [ Time Frame: Five years ]
- Cancer specific survival [ Time Frame: 5 years ]
- Local recurrence verified by needle or surgical biopsy [ Time Frame: Five years ]
- Adverse events [ Time Frame: Five years ]

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

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
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 |
radiotherapy, adjuvant prostatectomy |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |