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Safety Study of a Shorter (Hypofractionated) Radiotherapy for the Prostate Bed With or Without the Pelvic Lymph Nodes (PRIAMOS)

This study is currently recruiting participants.
Verified June 2012 by University of Heidelberg
Sponsor:
Information provided by (Responsible Party):
Klaus Herfarth - Dr. J. Debus, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01620710
First received: June 13, 2012
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Radiation: hypofractionated helical IMRT
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hypofractionated Helical Intensity-Modulated Radiotherapy of the Prostate Bed After Prostatectomy With or Without the Pelvic Lymph Nodes - the PRIAMOS Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • proportion SDR of patients with no grade III/IV toxicity and/or treatment discontinuation [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • biochemical recurrence free survival (BFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Quality of Life Scores as measured by the EORTC-QLQ30 and -PR25 questionnaires

  • overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: February 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
prostate bed Radiation: hypofractionated helical IMRT
hypofractionated helical IMRT of the prostate bed, 18 x 3 Gy
prostate bed & lymph nodes Radiation: hypofractionated helical IMRT
helical IMRT of the prostate bed (18 x 3 Gy) and the pelvic lymph nodes (18 x 2.5 Gy)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01620710

Contacts
Contact: Klaus Herfarth, MD +49-6221-568202 klaus.herfarth@med.uni-heidelberg.de
Contact: Sonja Krause, MD +49-6221-568202 sonja.krause@med.uni-heidelberg.de

Locations
Germany
Dep. of Radiation Oncology, University Hospital of Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Renate Haselmann     +49-6221-5638613     renate.haselmann@med.uni-heidelberg.de    
Principal Investigator: Klaus Herfarth, MD            
Sub-Investigator: Sonja Krause, MD            
Sponsors and Collaborators
University of Heidelberg
Investigators
Principal Investigator: Klaus Herfarth, MD University of Heidelberg
  More Information

No publications provided by University of Heidelberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Klaus Herfarth - Dr. J. Debus, Principal Inverstigator, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01620710     History of Changes
Other Study ID Numbers: PRIAMOS
Study First Received: June 13, 2012
Last Updated: June 15, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Heidelberg:
prostatectomy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013