Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006442

Trial Description

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Title

Hypofractionated Helical Intensity-Modulated Radiotherapy of the Prostate Bed After Prostatectomy With or Without the Pelvic Lymph Nodes - the PRIAMOS Trial

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Trial Acronym

PRIAMOS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This trial investigates safety and feasibility of a hypofractionated radiotherapy (i.e. with
higher daily doses and shorter total treatment time compared to standard fractionation) of
the prostate bed with or without the pelvic lymph nodes.

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Brief Summary in Scientific Language

While evidence on safety and efficacy of primary hypofractionated radiotherapy in prostate
cancer is accumulating, data on postoperative hypofractionated treatment of the prostate bed
and of the pelvic lymph nodes is still scarce. This phase II trial was initiated to
investigate safety and feasibility of hypofractionated treatment of the prostate bed alone
or with the pelvic lymph nodes.

A total of 80 prostate cancer patients with the indication for adjuvant radiotherapy will be
enrolled, where 40 patients with a low risk of lymph node involvement (arm 1) and another 40
patients with a high risk of lymph node involvement (arm 2) will each receive 54 Gy in 18
fractions to the prostate bed. Arm 2 will be given 45 Gy to the pelvic lymph nodes
additionally. Helical Tomotherapy and daily image guidance wil be used.

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Organizational Data

  •   DRKS00006442
  •   2015/03/17
  •   2012/06/13
  •   yes
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT01620710  (ClinicalTrials.gov)
  •   PRIAMOS  (Heidelberg University)
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Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Radiation: hypofractionated helical IMRT
  •   Radiation: hypofractionated helical IMRT
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
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Primary Outcome

- proportion SDR of patients with no grade III/IV toxicity and/or treatment discontinuation; time frame: 2 years; Proportion SDR of patients with no NCI CTC AE grade 3-4 toxicity and no discontinuation of treatment during the full set of 18 fractions by any reasons in the intent-to-treat (ITT) population

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Secondary Outcome

- biochemical recurrence free survival (BFS); time frame: 2 years
- Quality of Life; time frame: 2 years; Quality of Life Scores as measured by the EORTC-QLQ30 and -PR25 questionnaires
- overall survival; time frame: 2 years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2012/02/27
  •   80
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Inclusion Criteria

  •   Male
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

- resected prostate carcinoma with histological grading (Gleason Score)

- status post prostatectomy for a pT3 carcinoma and/or R1/2 resection or PSA recurrence
after prostatectomy (2 consecutive PSA rises)

- PSA recurrence ≥ 1 ng/ml: CT/PET/MRI imaging excluding pathological lymph nodes

- Karnofksy performance score ≥ 70 %

- age 18 - 80 years

- only arm 2: antihormonal therapy for 2 months prior to radiotherapy and continuation
of hormonal suppression after radiotherapy recommended

- written informed consent

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Exclusion Criteria

- patient's refusal

- patient's inabillity to give informed consent

- stage IV (distant metastases)

- lymph node involvement outside the pelvis

- severe wound complications after laparatomy

- only arm 2: severe lymphoedema of the legs, elephantiasis, postthrombotic syndrome

- decompensated pulmonary, cardiovascular, metabolic, hematopoetic, coagulatory or
renal comorbidities

- known other malignant disease with distant metastases

- prior pelvic irradiation

- participation in another clinical trial that might compromise the results of the
PRIAMOS trial or the other trial

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Addresses

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    • Heidelberg University
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    • Heidelberg University
    • Klaus Herfarth, MD 
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    •   [---]*
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    • Heidelberg University
    • Klaus Herfarth, MD 
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    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.