Status:
COMPLETED
Radiotherapy of the Prostate and the Pelvic Lymph Nodes After Neoadjuvant Antihormonal Treatment
Lead Sponsor:
Heidelberg University
Collaborating Sponsors:
Klaus Tschira Stiftung gGmbH
Conditions:
Prostate Cancer
Eligibility:
MALE
18-75 years
Phase:
PHASE2
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 rad...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT01903408
Start Date
May 1 2009
End Date
May 1 2020
Last Update
February 1 2023
Active Locations (1)
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1
Department of Radiation Oncology, University Hospital Heidelberg
Heidelberg, Germany, 69120