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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
hypofractionated helical IMRT
hypofractionated helical IMRT
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostatectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dep. of Radiation Oncology, University Hospital of Heidelberg

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

prostate bed

prostate bed & lymph nodes

Arm Description

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

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)

Outcomes

Primary Outcome Measures

proportion SDR of patients with no grade III/IV toxicity and/or treatment discontinuation
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)
Quality of Life
Quality of Life Scores as measured by the EORTC-QLQ30 and -PR25 questionnaires
overall survival

Full Information

First Posted
June 13, 2012
Last Updated
October 13, 2018
Sponsor
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT01620710
Brief Title
Safety Study of a Shorter (Hypofractionated) Radiotherapy for the Prostate Bed With or Without the Pelvic Lymph Nodes
Acronym
PRIAMOS
Official Title
Hypofractionated Helical Intensity-Modulated Radiotherapy of the Prostate Bed After Prostatectomy With or Without the Pelvic Lymph Nodes - the PRIAMOS Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 2012 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostatectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
prostate bed
Arm Type
Other
Arm Description
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
Arm Title
prostate bed & lymph nodes
Arm Type
Other
Arm Description
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)
Intervention Type
Radiation
Intervention Name(s)
hypofractionated helical IMRT
Intervention Description
hypofractionated helical IMRT of the prostate bed, 18 x 3 Gy
Intervention Type
Radiation
Intervention Name(s)
hypofractionated helical IMRT
Intervention Description
helical IMRT of the prostate bed (18 x 3 Gy) and the pelvic lymph nodes (18 x 2.5 Gy)
Primary Outcome Measure Information:
Title
proportion SDR of patients with no grade III/IV toxicity and/or treatment discontinuation
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
biochemical recurrence free survival (BFS)
Time Frame
2 years
Title
Quality of Life
Description
Quality of Life Scores as measured by the EORTC-QLQ30 and -PR25 questionnaires
Time Frame
2 years
Title
overall survival
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Herfarth, MD
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. of Radiation Oncology, University Hospital of Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25216858
Citation
Katayama S, Striecker T, Kessel K, Sterzing F, Habl G, Edler L, Debus J, Herfarth K. Hypofractionated IMRT of the prostate bed after radical prostatectomy: acute toxicity in the PRIAMOS-1 trial. Int J Radiat Oncol Biol Phys. 2014 Nov 15;90(4):926-33. doi: 10.1016/j.ijrobp.2014.07.015. Epub 2014 Sep 9.
Results Reference
result
PubMed Identifier
23114055
Citation
Krause S, Sterzing F, Neuhof D, Edler L, Debus J, Herfarth K. Hypofractionated helical intensity-modulated radiotherapy of the prostate bed after prostatectomy with or without the pelvic lymph nodes - the PRIAMOS trial. BMC Cancer. 2012 Oct 31;12:504. doi: 10.1186/1471-2407-12-504.
Results Reference
derived

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

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