Trial document




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  DRKS00003472

Trial Description

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Title

Salvage lymph node dissection with adjuvant radiotherapy for Choline-PET-CT positive lymph node metastases in patients with nodal recurrence of prostate cancer

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Trial Acronym

Salvage lymphadenectomy for nodal prostate cancer recurrence

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URL of the Trial

[---]*

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Brief Summary in Lay Language


Prostate cancer represents the most commonly diagnosed malignant tumor in men and is responsible for 11% of deaths. For tumors requiring treatment, radical removal of the prostate and radiation therapy represents options with curative intent. Despite initial good clinical results, dependent on tumor stage, in about 17-40% after primary therapy biochemical recurrence occurs. Biochemical recurrence is diagnosed by rising oft the tumor-marker PSA (prostate specific antigen) in serum. Bone metastases as a cause of prostate cancer relapse is linked to poor prognosis and survival and rules out a possible cure.

However, the question of prognosis and adequate treatment for men with exclusively nodal prostate cancer recurrence is completely unanswered.

The current standard treatment for these patients is hormonal castration and finally chemotherapy. Antihormonal therapy leads to severe side effects and has limited effects due to the development of a hormone refractory tumor stage.

Every form of systemic standard therapy for prostate cancer, like castration and chemotherapy, has no curative properties and invariably leads to a refractory tumor stage with poor prognosis. Alternative established approaches to hormonal therapy for patients with nodal prostate cancer recurrence are not available.


In literature and present studies patients with bone and lymph node metastases had been “historically” summarized to one group. Furthermore it is challenging to diagnose lymph node metastases by conventional imaging (CT, MRI).
Nowadays, due to excellent enrichment of radionuclides 11C-choline and 18F-choline especially in lymph node metastases it is possible to distinguish with high reliability between healthy lymph nodes from affected lymph nodes by Choline-PET-CT.

The aim of this retrospective study is to analysis 52 salvage lymphadenectomies, based on Choline-PET-CT findings, performed in 47 patients with nodal prostate cancer recurrence.

Furthermore, we want to analyze whether a PSA-reduction in terms of curation can be achieved by surgical removal of lymph node metastases, or wether the therapeutic influence is only temporary. We also will analyze which patients are suitable for such treatment and which factors will influence success or failure.

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Brief Summary in Scientific Language








Prostate cancer represents with 29% the most commonly diagnosed malignant tumor in men and is responsible for 11% of deaths.

For tumors requiring treatment, radical removal of the prostate (radical prostatectomy with primary pelvic lymphadenectomy) and radiation therapy represents options with curative intent.

Despite initial good clinical results, dependent on tumor stage, in about 17-40% after primary therapy biochemical recurrence occurs. Biochemical recurrence is diagnosed by rising oft the tumor-marker PSA (prostate specific antigen) in serum.

Bone metastases or visceral metastases as a cause of prostate cancer relapse is linked to poor prognosis and survival and rules out a possible cure.

However, the question of prognosis and adequate treatment for men with exclusively nodal prostate cancer recurrence completely unanswered.

The current standard treatment for these patients is hormone deprivation therapy and finally chemotherapy. Antihormonal therapy leads to severe side effects and has limited effects due to the development of a hormone refractory tumor stage.

Every form of systemic standard therapy for prostate cancer, like castration and chemotherapy, has no curative properties, and invariably leads to a refractory tumor stage with poor prognosis. Alternative established approaches to hormonal therapy for patients with nodal prostate cancer recurrence are not available.


In literature and present studies patients with bone and lymph node metastases had been “historically” summarized to one group. Furthermore it is challenging to diagnose lymph node metastases in conventional imaging (CT, MRI).
Nowadays, by an excellent enrichment of radionuclides 11C-choline and 18F-choline especially in lymph node metastases it is possible to distinguish by application of Choline-PET-CT with high reliability between healthy lymph nodes from affected lymph nodes.

The aim of this retrospective study is to analysis 52 salvage lymphadenectomies, based on Choline-PET-CT diagnostics, performed in 47 patients with nodal prostate cancer recurrence.

Furthermore, we want to analyze whether a PSA-reduction in terms of curation can be achieved by surgical removal of lymph node metastases, or wether the therapeutic influence is only temporary. We also will analyze which patients are suitable for such treatment and which factors will influence success or failure.

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Organizational Data

  •   DRKS00003472
  •   2012/05/29
  •   [---]*
  •   yes
  •   Approved
  •   135/12, 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
  •   C77 -  Secondary and unspecified malignant neoplasm of lymph nodes
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Interventions/Observational Groups

  •   salvage lymph node dissection with adjuvant radiotherapy
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

PSA-progression free survival

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Secondary Outcome

clinical progression of prostate cancer
tumor specific and overall survival

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/05/01
  •   47
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

Patients with biochemical relapse after radical prostatectomy or primary radiotherapy, evidence (11C-choline or 18F-fluorethylcholin-PET-CT) for nodal recurrence of PCA , Charlson-Comorbidity-index ≤ 2, age <80 years.

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Exclusion Criteria

Presence of bone or visceral metastases, Charlson-Comorbidity-index > 2, age > 80 years, presence of untreated local recurrence in prostatic fossa, continuation of anti hormonal therapy

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Str. 55
    • 79098  Freiburg
    • Germany
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    •   [---]*
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    • Universitätsklinikum Freiburg, Urologische Klinik
    • Ms.  Dr. med.  Cordula  Jilg 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Urologische Klinik
    • Ms.  Dr. med.  Cordula  Jilg 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik Freiburg Abteilung Urologie
    • Mr.  Prof. Dr.  Ulrich  Wetterauer 
    • Hugstetterstraße 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/06/30
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Trial Publications, Results and other Documents

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Additional Trial Attributes

  • Urological disease 
  • If other, please specify 
  • Study recommendations 
  • If other, please specify 
  • German director of clinical investigation 
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    • [---]*
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  • Further contact 
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  • Function of contact 
  • Non-interventional study 
  • Stage 
  • If other, please specify 
  • Onset of therapy 
  • If other, please specify 
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* This entry means the parameter is not applicable or has not been set.