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

NCT02668718 | Unknown Phase 3

• 1 other identifier: FP-FINROG-0301
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostatic Neoplasms

Keywords

radiotherapy, adjuvant; prostatectomy

Outcome Measures

Primary Outcomes (3)

• Biochemical disease-free survival

  Five years

• Overall survival

  Five years

• Cancer specific survival

  5 years

Secondary Outcomes (2)

• Local recurrence verified by needle or surgical biopsy

  Five years

• Adverse events

  Five years

Study Arms (2)

Adjuvant radiotherapy

OTHER

Patients who were randomized to adjuvant radiotherapy following radical prostatectomy

Radiation: Adjuvant radiotherapy

Watchful waiting

NO INTERVENTION

Patients who were randomized to watchful waiting following radical prostatectomy

Interventions

Adjuvant radiotherapy RADIATION

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.

Adjuvant radiotherapy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Radiotherapy

Study Officials

• Teuvo Tammela, M.D., Ph.D.

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D., Professor of Surgery

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: January 29, 2016
• Study Start: March 1, 2004
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 2, 2016

Record last verified: 2016-02