Radiotherapy of the Prostate and the Pelvic Lymph Nodes After Neoadjuvant Antihormonal Treatment
- Conditions
- Prostate Cancer
- Interventions
- Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB
- Registration Number
- NCT01903408
- Lead Sponsor
- Heidelberg University
- Brief Summary
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.
- Detailed Description
The PLATIN trial is designed as a prospective, non-randomized, five-arm trial. Arm 1: Definitive radiotherapy of the pelvic lymphatic drainage with integrated boost to the prostate.
Arm 2: As arm 1, with additional boost to macroscopic lymph node metastases. Arm 3: Postoperative radiotherapy of the pelvic lymphatic drainage with integrated boost to the prostate bed.
Arm 4: As arm 3, additional boost to macroscopic lymph node metastases. Arm 5: Patients with previous radiotherapy to the prostate bed. Radiotherapy of the pelvic lymphatic drainage above the previous treatment fields with integrated boost to macroscopic lymph node metastases.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 199
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 4: Boost to prostate bed and lymph node metastases Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB IMRT of the pelvic lymphatic drainage (51 Gy), SIB to the prostate bed 68 Gy) \& lymph node metastases (61.2 Gy) in 34 Fx Arm 1: Boost to prostate Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB 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 Arm 2: Boost to prostate and lymph node metastases Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB 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 Arm 3: Boost to prostate bed Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB IMRT of the pelvic lymphatic drainage (51 Gy) and integrated boost to the prostate bed (68 Gy) in 34 fractions Arm finished recruitment and follow-up and is published Arm 5: Boost to lymph node metastases Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB Patients with previous irradiation of the prostate bed: IMRT of the pelvic lymphatic drainage (46.8 Gy) above the previous treatment fields, SIB to lymph node metastases (63.2 Gy) in 26 Fx
- Primary Outcome Measures
Name Time Method Rate of safe feasibility (SDR) 2 years Proportion of treatments begun as planned without grade 3-4 NCI common toxicity criteria adverse events (CTC AE) or treatment disruption among all patients that fulfill inclusion criteria and have been treated according to trial protocol for at least a week.
- Secondary Outcome Measures
Name Time Method Biochemical recurrence free survival 2 years Quality of Life 2 years Measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30
Trial Locations
- Locations (1)
Department of Radiation Oncology, University Hospital Heidelberg
🇩🇪Heidelberg, Germany