Clinical trial · Interventional
Safety Study of a Shorter (Hypofractionated) Radiotherapy for the Prostate Bed With or Without the Pelvic Lymph Nodes
Hypofractionated Helical Intensity-Modulated Radiotherapy of the Prostate Bed After Prostatectomy With or Without the Pelvic Lymph Nodes - the PRIAMOS Trial
NCT01620710CI-TRIAL-00035294PRIAMOScompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial investigates safety and feasibility of a hypofractionated radiotherapy (i.e. with higher daily doses and shorter total treatment time compared to standard fractionation) of the prostate bed with or without the pelvic lymph nodes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hypofractionated helical IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- prostate bed
- description
- irradiation of the prostatic bed only (no higher risk of lymph node recurrence); helical IMRT of the prostate bed (18 x 3 Gy) This arm has already finished recruitment
- interventionNames
- Radiation: hypofractionated helical IMRT
- type
- OTHER
- label
- prostate bed & lymph nodes
- description
- irradiation of the prostatic bed and the pelvic lymphatic drainage (in patients with higher risk of lymph node recurrence); helical IMRT of the prostate bed (18 x 3 Gy) and the pelvic lymph nodes (18 x 2.5 Gy)
- interventionNames
- Radiation: hypofractionated helical IMRT
Primary outcomes (1)
- measure
- proportion SDR of patients with no grade III/IV toxicity and/or treatment discontinuation
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * resected prostate carcinoma with histological grading (Gleason Score) * status post prostatectomy for a pT3 carcinoma and/or R1/2 resection or PSA recurrence after prostatectomy (2 consecutive PSA rises) * PSA recurrence ≥ 1 ng/ml: CT/PET/MRI imaging excluding pathological lymph nodes * Karnofksy performance score ≥ 70 % * age 18 - 80 years * only arm 2: antihormonal therapy for 2 months prior to radiotherapy and continuation of hormonal suppression after radiotherapy recommended * written informed consent Exclusion Criteria: * patient's refusal * patient's inabillity to give informed consent * stage IV (distant metastases) * lymph node involvement outside the pelvis * severe wound complications after laparatomy * only arm 2: severe lymphoedema of the legs, elephantiasis, postthrombotic syndrome * decompensated pulmonary, cardiovascular, metabolic, hematopoetic, coagulatory or renal comorbidities * known other malignant disease with distant metastases * prior pelvic irradiation * participation in another clinical trial that might compromise the results of the PRIAMOS trial or the other trial
References
Publications (2)
- RESULTKatayama S, Striecker T, Kessel K, Sterzing F, Habl G, Edler L, Debus J, Herfarth K. Hypofractionated IMRT of the prostate bed after radical prostatectomy: acute toxicity in the PRIAMOS-1 trial. Int J Radiat Oncol Biol Phys. 2014 Nov 15;90(4):926-33. doi: 10.1016/j.ijrobp.2014.07.015. Epub 2014 Sep 9. PMID 25216858
- DERIVEDKrause S, Sterzing F, Neuhof D, Edler L, Debus J, Herfarth K. Hypofractionated helical intensity-modulated radiotherapy of the prostate bed after prostatectomy with or without the pelvic lymph nodes - the PRIAMOS trial. BMC Cancer. 2012 Oct 31;12:504. doi: 10.1186/1471-2407-12-504. PMID 23114055