Radiotherapy of the Prostate and the Pelvic Lymph Nodes After Neoadjuvant Antihormonal Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prostate and Whole Pelvis Irradiation With Integrated-boost Intensity-modulated Radiotherapy (IMRT) After Neoadjuvant Antihormonal Treatment - a Phase II Trial

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1: Boost to prostate<br>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 | Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB<br>* The intervention is the use of modern radiation techniques with simultaneous integrated boost (SIB)<br>|
| Other: Arm 2: Boost to prostate and lymph node metastases<br>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 | Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB<br>* The intervention is the use of modern radiation techniques with simultaneous integrated boost (SIB)<br>|
| Other: Arm 3: Boost to prostate bed<br>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 | Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB<br>* The intervention is the use of modern radiation techniques with simultaneous integrated boost (SIB)<br>|
| Other: Arm 4: Boost to prostate bed and lymph node metastases<br>IMRT of the pelvic lymphatic drainage (51 Gy), SIB to the prostate bed 68 Gy) & lymph node metastases (61.2 Gy) in 34 Fx | Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB<br>* The intervention is the use of modern radiation techniques with simultaneous integrated boost (SIB)<br>|
| Other: Arm 5: Boost to lymph node metastases<br>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 | Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB<br>* The intervention is the use of modern radiation techniques with simultaneous integrated boost (SIB)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of safe feasibility (SDR) | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical recurrence free survival |  | 2 years | 
| Quality of Life | Measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 | 2 years |