Multicenter randomized phase-III trial into adjuvant radiotherapy for prostate cancer patients with or without positive surgical margins post-prostatectomy and with low level lymph node involvement (mircrometastases, =2 lymph node macrometastases)
- Conditions
- C61Malignant neoplasm of prostate
- Registration Number
- DRKS00004733
- Lead Sponsor
- Klinik für Strahlentherapie und RadioonkologieUniversitätsklinikum Ulm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- Male
- Target Recruitment
- 25
Status post radical prostatectomy (incl. nerve-sparing) with histologically confirmed stage pTx R0/R1 pN+ (micrometastases, 1-2 macrometastases with or without additional micrometastases);
extended lymphadenectomy (=12 lymph nodes) ;
pre-OP PSA <50 ng/mL ;
negative pre-OP bone scintigram (obligatory for PSA >20 ng/mL or bioptic Gleason Score 8-10) ;
pre-OP abdominal and pelvic CT without pathological findings (obligatory for PSA >20 ng/mL or bioptic Gleason Score 8-10);
Consensus between local and central pathology on pT stage, surgical margin status, Gleason Score and lymph node status ;
Response to prostatectomy confirmed by achieving within 90 days post-OP a PSA nadir <0.1 ng/mL (undetectable) ;
Age =40 years ;
Karnofsky Index > 80% ;
Capability and will to adhere to study conditions ;
Written informed consent to participate in the study
Persisting complete incontinence (grade III) ;
Tumour stage pN0 ;
>2 lymph nodes involved macroscopically ;
distant metastases ;
Previous or actual inflammation of the large intestine ;
Previous radiotherapy to the true pelvis ;
Previous chemotherapy ;
Status post bilateral orchiectomy ;
Status after pre-OP neoadjuvant hormone therapy ;
Previous or actual post-OP medical hormone therapy ;
Presence of a second tumour except curatively treated basalioma ;
Previous or actual psychiatric disorder or addiction ;
Participation in another clinical study, concurrent or within the last three months before the start of ART-2 ;
Inability to understand the study purpose or to adhere to study conditions ;
Missing written informed consent
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival, maximum follow-up 9 years
- Secondary Outcome Measures
Name Time Method Overall survival (scheduled follow-up max. 9 years) ; <br>Distant metastases ;<br>Rate of acut side effects of radiotherapy ;<br>Rate of late side effects: Bladder/Urethra and intestine according to RTOG ;<br>Quality of life (EORTC query QLQ-C30 after 3-6-12-24-60 months) ; <br>Erectile dysfunction (International Index of Erectile Function, query form IIEF after 3-6-12-24-60 months)