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

October 13, 2018 updated by: Klaus Herfarth, MD, Heidelberg University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • Dep. of Radiation Oncology, University Hospital of Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: prostate bed

irradiation of the prostatic bed only (no higher risk of lymph node recurrence); helical IMRT of the prostate bed (18 x 3 Gy)

This arm has already finished recruitment
Radiation: hypofractionated helical IMRT
hypofractionated helical IMRT of the prostate bed, 18 x 3 Gy
Radiation: hypofractionated helical IMRT
helical IMRT of the prostate bed (18 x 3 Gy) and the pelvic lymph nodes (18 x 2.5 Gy)
Other: prostate bed & lymph nodes
irradiation of the prostatic bed and the pelvic lymphatic drainage (in patients with higher risk of lymph node recurrence); helical IMRT of the prostate bed (18 x 3 Gy) and the pelvic lymph nodes (18 x 2.5 Gy)
Radiation: hypofractionated helical IMRT
hypofractionated helical IMRT of the prostate bed, 18 x 3 Gy
Radiation: hypofractionated helical IMRT
helical IMRT of the prostate bed (18 x 3 Gy) and the pelvic lymph nodes (18 x 2.5 Gy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 2 years
2 years
biochemical recurrence free survival (BFS)
Time Frame: 2 years
2 years
Quality of Life
Time Frame: 2 years
Quality of Life Scores as measured by the EORTC-QLQ30 and -PR25 questionnaires
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

  • Principal Investigator: Klaus Herfarth, MD, Heidelberg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2012

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 30, 2017

Study Registration Dates

First Submitted

June 13, 2012

First Submitted That Met QC Criteria

June 13, 2012

First Posted (Estimate)

June 15, 2012

Study Record Updates

Last Update Posted (Actual)

October 16, 2018

Last Update Submitted That Met QC Criteria

October 13, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRIAMOS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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