Clinical trial · Interventional
Radiotherapy of the Prostate and the Pelvic Lymph Nodes After Neoadjuvant Antihormonal Treatment
Prostate and Whole Pelvis Irradiation With Integrated-boost Intensity-modulated Radiotherapy (IMRT) After Neoadjuvant Antihormonal Treatment - a Phase II Trial
- 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)
For patients with prostate cancer and a high risk of lymph node involvement or confirmed pelvic lymph node metastases, radiotherapy of the whole pelvis is a treatment option. However, conventional radiotherapy of the pelvis has limited by gastrointestinal and urogenital side effects. The PLATIN trial investigates an intensity-modulated radiotherapy of the pelvic lymphatic drainage that spares small bowel, bladder and rectum. A higher dose is given during each session to the prostate or the prostate bed and to confirmed lymph node metastases. Prior to radiotherapy, two months of neoadjuvant antihormonal treatment are required, and continuation during radiotherapy and for a further two years are strongly recommended.
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 |
|---|---|---|---|
| Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- OTHER
- label
- Arm 1: Boost to prostate
- description
- IMRT of the pelvic lymphatic drainage (51 Gy) and integrated boost to the prostate (76.5 Gy) in 34 fractions Arm finished recruitment and follow-up
- interventionNames
- Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB
- type
- OTHER
- label
- Arm 2: Boost to prostate and lymph node metastases
- description
- IMRT of the pelvic lymphatic drainage (51 Gy), SIB to the prostate (76.5 Gy) \& pelvic lymph node mets (61.2 Gy) in 34 Fx
- interventionNames
- Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB
- type
- OTHER
- label
- Arm 3: Boost to prostate bed
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed prostate cancer with Gleason Score * risk of lymph node involvement \>20% (according to Roach Formula), pelvic lymph node metastases in CT/MRI or histologically confirmed lymph node involvement * Karnofsky Index \>/= 70% * age 18-75 years * neoadjuvant antihormonal treatment for 2 months, continuation until the end of radiotherapy * written informed consent Exclusion Criteria: * stage IV (distant metastases) * lymph node metastases outside the pelvis * rising prostate-specific antigen (PSA) under antihormonal treatment * severe wound complications after laparatomy * severe lymph edema of the legs, elephantiasis, postthrombotic syndrome * decompensated comorbidity of the lungs, heart, metabolic system, hematopoetic system or kidneys, coagulopathy * history of other malignancy within the last 5 years (except for basal cell carcinoma or squamous carcinoma of the skin) * previous irradiation of the pelvic lymph nodes * concurrent participation in a clinical trial that might influence the results of either trial
References
Publications (3)
- RESULTHabl G, Katayama S, Uhl M, Kessel KA, Edler L, Debus J, Herfarth K, Sterzing F. Helical intensity-modulated radiotherapy of the pelvic lymph nodes with a simultaneous integrated boost to the prostate--first results of the PLATIN 1 trial. BMC Cancer. 2015 Nov 7;15:868. doi: 10.1186/s12885-015-1886-5. PMID 26547188
- RESULTKatayama S, Habl G, Kessel K, Edler L, Debus J, Herfarth K, Sterzing F. Helical intensity-modulated radiotherapy of the pelvic lymph nodes with integrated boost to the prostate bed - initial results of the PLATIN 3 Trial. BMC Cancer. 2014 Jan 14;14:20. doi: 10.1186/1471-2407-14-20. PMID 24422782
- RESULTKoerber SA, Winter E, Katayama S, Slynko A, Haefner MF, Uhl M, Sterzing F, Habl G, Schubert K, Debus J, Herfarth K. Elective Node Irradiation With Integrated Boost to the Prostate Using Helical IMRT-Clinical Outcome of the Prospective PLATIN-1 Trial. Front Oncol. 2019 Aug 13;9:751. doi: 10.3389/fonc.2019.00751. eCollection 2019. PMID 31456941