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)

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) - ART-2 Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004733

Enrollment

298

Registered

2013-03-14

Start date

2014-04-03

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C61

Interventions

Group 1: Wait-and-See (W+S) after radical prostatectomy. Scheduled follow-up including PSA determination for early diagnosis of a potential (biochemical) relaps. In case of recurrence, antihormonal tr

with positive surgical margins boost to 64 Gy. (RapidArc, VMAT optional)

Eligibility

Sex/Gender

Male

Age

40 Years to No maximum

Inclusion criteria

Inclusion criteria: 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 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 80% ; Capability and will to adhere to study conditions ; Written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Progression-free survival, maximum follow-up 9 years	—

Secondary

Measure	Time frame
Overall survival (scheduled follow-up max. 9 years) ; Distant metastases ; Rate of acut side effects of radiotherapy ; Rate of late side effects: Bladder/Urethra and intestine according to RTOG ; Quality of life (EORTC query QLQ-C30 after 3-6-12-24-60 months) ; Erectile dysfunction (International Index of Erectile Function, query form IIEF after 3-6-12-24-60 months)	—

Countries

Germany

Contacts

Public ContactThomas Wiegel

Klinik für Strahlentherapie und Radioonkologie Universitätsklinikum Ulm

thomas.wiegel@uniklinik-ulm.de#49 731 500 56101

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026