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

• ClinicalTrials.gov Identifier: NCT02668718
• Recruitment Status: Unknown
• First Posted: January 29, 2016
• Last Update Posted: February 2, 2016
• Sponsor: Helsinki University Central Hospital
• Information provided by (Responsible Party): Teuvo Tammela, Tampere University Hospital

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.

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• 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.

Contacts and Locations

Sponsors and Collaborators

Helsinki University Central Hospital

Investigators

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

More Information

• 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
• 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