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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 : 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

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prostate and Whole Pelvis Irradiation With Integrated-boost Intensity-modulated Radiotherapy (IMRT) After Neoadjuvant Antihormonal Treatment - a Phase II Trial
Actual Study Start Date : May 2009
Actual Primary Completion Date : May 2018
Estimated Study Completion Date : May 2020

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Arm Intervention/treatment
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
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)

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
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)

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
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)

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
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)

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
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)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Biochemical recurrence free survival [ Time Frame: 2 years ]
  2. 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



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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903408


Locations
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Germany
Department of Radiation Oncology, University Hospital Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Klaus Tschira Stiftung gGmbH
Investigators
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Principal Investigator: Klaus Herfarth, Prof. Dr. University Hospital Heidelberg, Department of Radiation Oncology