Radiotherapy with scanning beam protons for locally advanced prostate cancer or localised prostate cancer with risk factors

Not Applicable

Completed

• Conditions: Cancer; Prostate cancer; Malignant neoplasm of prostate

• Registration Number: ISRCTN78176828
• Lead Sponsor: niversity Hospital Essen (Universitatsklinikum Essen) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-08
• Study Completion: 2015-04-01
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 240

Inclusion Criteria

1. Histologically confirmed prostate cancer with one of the following combinations:
1.1. T3-T4 or Gleason greater than or equal to 8 or prostate specific antigen (PSA) greater than 20 and less than 50 ng/ml
1.2. T1c-T2a and Gleason 7 and PSA greater than 10 and less than or equal to 20 ng/ml
1.3. T2b-T2c and Gleason 7 or PSA greater than 10 and less than or equal to 20 ng/ml
2. Performance status World Health Organization (WHO) less than or equal to 2
3. No evidence of distant metastases. Minimum work-up: a negative bone scan and an actual PSA-value within 2 months prior to registration are required.
4. Negative regional lymph nodes as established by staging lymphadenectomy. For patients denying staging lymphadenectomy, an actual computed tomography (CT) or magnetic resonance imaging (MRI) scan has to be negative for lymph node metastases.
5. Men of child-producing potential must be willing to consent to use effective contraception
6. Aged greater than or equal to 18 years
7. Patients must give study specific informed consent

Exclusion Criteria

1. PSA greater than or equal to 50 ng/ml
2. Evidence of distant metastases
3. Pathological proven positive lymph nodes or regional lymph nodes greater than 1.0 cm in the smallest diameter on imaging studies
4. Prior radical prostatectomy or cryosurgery for prostate cancer
5. History of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
6. Prior pelvic radiotherapy or brachytherapy
7. Prior systemic chemotherapy for the study cancer
8. Current or continuing anti-coagulation with Coumadin or equivalent
9. Transurethral resection of the prostate or urethrotomia less than 6 months before radiotherapy
10. Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any cancer
11. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
12. Severe, active co-morbidity, defined as follows:
12.1. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
12.2. Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
12.3. Hip implants
12.4. Major medical or psychiatric condition which in the investigators opinion will prevent completion of the treatment and interfere with follow-up
12.5. Pre-existing of those gastrointestinal (GI) or genitourinary (GU) symptoms of Grade greater than 1 on the Common Toxicity Criteria (CTC) late effect scale, that are considered for the primary end point

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of severe late GU and GI toxicity defined as grade 3 - 5 GU and GI complications according to Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) appearing or persisting greater than 120 days after treatment start at 24 months after treatment start (late treatment-related adverse events).

Secondary Outcome Measures

Name	Time	Method
<br> 1. Rate of biochemical failure<br> 2. Overall survival<br> 3. Disease specific survival<br> 4. Rate of clinical progressions and time to clinical progression - local/regional and distant relapse<br> 5. Acute toxicity (GU/GI) greater than or equal to grade 3 (CTC 3.0)<br> 6. Rate of acute grade 2 toxicity (GU/GI) (CTC 3.0)<br> 7. Rate of late grade greater than or equal to 2 GU and GI toxicity<br><br> Measured 24 months after treatment start. Acute toxicity is measured until 120 days after treatment start. A follow-up of 2 years after treatment start is required, however, a long term follow-up is recommended. Thus, rate of biochemical failure, overall survival, disease specific survival and rate of late toxicity will possibly be evaluated after 5 years and longer.<br>