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Trial record 1 of 1 for:    NCT01903408
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Radiotherapy of the Prostate and the Pelvic Lymph Nodes After Neoadjuvant Antihormonal Treatment (PLATIN)

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ClinicalTrials.gov Identifier: NCT01903408
Recruitment Status : Unknown
Verified October 2018 by Klaus Herfarth, MD, Heidelberg University.
Recruitment status was:  Active, not recruiting
First Posted : July 19, 2013
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
Klaus Tschira Stiftung gGmbH
Information provided by (Responsible Party):
Klaus Herfarth, MD, Heidelberg University

Tracking Information
First Submitted Date  ICMJE July 16, 2013
First Posted Date  ICMJE July 19, 2013
Last Update Posted Date October 17, 2018
Actual Study Start Date  ICMJE May 2009
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2013)
Rate of safe feasibility (SDR) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2013)
  • Biochemical recurrence free survival [ Time Frame: 2 years ]
  • Quality of Life [ Time Frame: 2 years ]
    Measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiotherapy of the Prostate and the Pelvic Lymph Nodes After Neoadjuvant Antihormonal Treatment
Official Title  ICMJE Prostate and Whole Pelvis Irradiation With Integrated-boost Intensity-modulated Radiotherapy (IMRT) After Neoadjuvant Antihormonal Treatment - a Phase II Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB
The intervention is the use of modern radiation techniques with simultaneous integrated boost (SIB)
Study Arms  ICMJE
  • 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
    Intervention: Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using 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
    Intervention: Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using 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
    Intervention: Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using 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
    Intervention: Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using 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
    Intervention: Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 13, 2018)
199
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2013)
200
Estimated Study Completion Date  ICMJE May 2020
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 2 Years to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01903408
Other Study ID Numbers  ICMJE Klaus Tschira 00.153.2009
ARO 2009-05 ( Registry Identifier: ARO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Klaus Herfarth, MD, Heidelberg University
Study Sponsor  ICMJE Heidelberg University
Collaborators  ICMJE Klaus Tschira Stiftung gGmbH
Investigators  ICMJE
Principal Investigator: Klaus Herfarth, Prof. Dr. University Hospital Heidelberg, Department of Radiation Oncology
PRS Account Heidelberg University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP