Radiotherapy of the Prostate and the Pelvic Lymph Nodes After Neoadjuvant Antihormonal Treatment
NCT ID: NCT01903408
Last Updated: 2023-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
199 participants
INTERVENTIONAL
2009-05-31
2020-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: Boost to prostate
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
Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB
The intervention is the use of modern radiation techniques with simultaneous integrated boost (SIB)
Arm 2: Boost to prostate and lymph node metastases
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
Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB
The intervention is the use of modern radiation techniques with simultaneous integrated boost (SIB)
Arm 3: Boost to prostate bed
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
Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB
The intervention is the use of modern radiation techniques with simultaneous integrated boost (SIB)
Arm 4: Boost to prostate bed and lymph node metastases
IMRT of the pelvic lymphatic drainage (51 Gy), SIB to the prostate bed 68 Gy) \& lymph node metastases (61.2 Gy) in 34 Fx
Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB
The intervention is the use of modern radiation techniques with simultaneous integrated boost (SIB)
Arm 5: Boost to lymph node metastases
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
Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB
The intervention is the use of modern radiation techniques with simultaneous integrated boost (SIB)
Interventions
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Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB
The intervention is the use of modern radiation techniques with simultaneous integrated boost (SIB)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
MALE
No
Sponsors
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Klaus Tschira Stiftung gGmbH
UNKNOWN
Heidelberg University
OTHER
Responsible Party
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Klaus Herfarth, MD
Principal Investigator
Principal Investigators
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Klaus Herfarth, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Heidelberg, Department of Radiation Oncology
Locations
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Department of Radiation Oncology, University Hospital Heidelberg
Heidelberg, , Germany
Countries
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References
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Habl 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.
Katayama 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.
Koerber 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.
Other Identifiers
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ARO 2009-05
Identifier Type: REGISTRY
Identifier Source: secondary_id
Klaus Tschira 00.153.2009
Identifier Type: -
Identifier Source: org_study_id
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