Trial document




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  DRKS00010497

Trial Description

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Title

Salvage lymphadenectomy with or without adjuvant radiation therapy for prostate cancer recurrence

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Trial Acronym

SALPRO

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Purpose of this study is in patients with a lymph node positive prostate carcinoma recurrence the effect of salvage radiotherapy after a salvage lymphadenectomy on PSA progression, radiological progression, to investigate hormonotherapy-free survival time, tumor-specific survival time, overall survival time and tolerability (toxicity). Patients with a local recurrence after radical prostatectomy are treated with salvage radiation therapy. This can have a significant positive effect on PSA progression-free survival and overall survival, giving patients a second chance of recovery.

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Organizational Data

  •   DRKS00010497
  •   2018/05/15
  •   [---]*
  •   yes
  •   Approved
  •   418/17, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
  •   Prostate Carcinoma, Salvage lymphadenectomy
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Interventions/Observational Groups

  •   Salvage lymphadenectomy with radiation therapy
  •   Salvage lymphadenectomy without radiation therapy
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

PCA Progression-free survival time; Radiological Progression-free survival time

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Secondary Outcome

- hormone therapy free survival;
- Tumor-specific survival time;
- Overall survival;
- Drug toleranca, side effects and toxicity of salvage Lymphadenektomy and adjuvant radiation therapy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/05/16
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

1) capacity and patient compliance;
2) primary therapy prostate cancer (excluding z.n. radical prostatectomy)
3) presence of biochemical recurrence (PSA> 0,2ng/ml in two consecutive measurements at Z.n. radical prostatectomy)
4) Morphological imaging (excluded 68Ga-PSMA-PET / CT) suspencion of lymph node metastases (pelvis up including aortic bifurcation, solitary or multiple)
5) presence of imaging (excluded 68Ga-PSMA-PET / CT) for the diagnosis of lymph node metastasis (≤ 4 months old)
6) In case of antihormonal therapy these 4 weeks should be discontinued prior to planned salvage lymphadenectomy
7) Hematological, blood coagulation, hepatic and renal functions in the normal range (as part of the routine preparation for surgery)

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Exclusion Criteria

1) detection of distant metastases (Soft-tissue metastasis an/or bone metastases and/or visceral metastases, and/or lymph node metastases above the bifurcation)
2)radiotherapy as primary therapy
3) Untreated malignancies or evidence of another tumor, which limits the life expectancy of the patient leader
4) Charlson Comorbidity Index> 2
5) ECOG performance score> 1
6) myocardial infarction or apoplexy within the last 6 months
7) Existing major cardiovascular (grade III - IV according to NYHA), pulmonary (pO2 <60 mmHg), renal, hepatic or hematopoietic (f.e. severe bone marrow aplasia) disease
8) acute and chronic infection (f.e. HIV Ab test, HBs-Ag detection in serum and / or chronic hepatitis)
9) Severe psychiatric disorders persons housed on judicial or administrative arrangement in an institution
10) Simultaneous participation in another clinical trial with interventional character (simultaneous participation in registry studies and / or non-interventional studies is allowed)
11) Subjects, who are standing in the work relationship / or relationship of dependency with Principal investigator or having any condition which, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).

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Addresses

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    • Universitätsklinikum FreiburgKlinik für Urologie
    • Ms.  Prof. Dr.  Cordula Annette  Jilg 
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Universitätsklinikum FreiburgKlinik für Urologie
    • Ms.  PD DR.  Cordula Annette  Jilg 
    • Hugstterstr. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Klinik für Urologie,Studiensekretariat
    • Ms.  Katrin  Meumann 
    • Hugstetter Straße 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum FreiburgKlinik für Urologie
    • Hugstter Straße 55
    • 79106  Freiburg
    • Germany
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    • Stiftung Deutsche Krebshilfe
    • Buschstr. 32
    • 53113  Bonn
    • Germany
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Status

  •   Recruiting stopped after recruiting started
  •   2018/12/04
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Trial Publications, Results and other Documents

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