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Clinical Trials/NCT04083937
NCT04083937
Recruiting
Not Applicable

Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies

University Hospital Heidelberg1 site in 1 country897 target enrollmentSeptember 12, 2018

Overview

Phase
Not Applicable
Intervention
Normofractionated radiotherapy with photons
Conditions
Prostate Cancer
Sponsor
University Hospital Heidelberg
Enrollment
897
Locations
1
Primary Endpoint
Quality of life (prostate-associated, 12 weeks vs baseline)
Status
Recruiting
Last Updated
last month

Overview

Brief Summary

As the most common male carcinoma, prostate cancer is a major tumor entity in oncology. In addition to definitive radiotherapy, surgical procedure is considered to be an oncologically equivalent therapeutic alternative for non-metastatic malignancies in the primary setting. However, a subsequent radiotherapy of the prostate bed is often necessary, which takes place as an "adjuvant" treatment immediately after surgery or in the course of a repeated increase in PSA and usually extends over several weeks. For the primary situation (without previous surgery), several randomized phase III clinical trials have shown that it is possible to shorten radiotherapy by increasing the single dose (called hypofractionation). In the context of two prospective Phase II studies, which were carried out in Heidelberg, it has since been shown that hypofractionation with both photons and protons is safe and feasible even in the postoperative situation.

The current, prospective and randomized PAROS study is now intended to demonstrate a multicentric phase III study as an improvement in the quality of life caused by rectum toxicity (primary endpoint) by the use of protons. The oncological non-inferiority of hypofractionated radiotherapy after surgery is a secondary endpoint.

Registry
clinicaltrials.gov
Start Date
September 12, 2018
End Date
January 1, 2029
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Juergen Debus

Principal Investigator

University Hospital Heidelberg

Eligibility Criteria

Inclusion Criteria

  • histology-proven prostate cancer with Gleason Score and PSA-value;
  • indication for prostate bed irradiation (adjuvant/ salvage) after prostatectomy;
  • Karnofsky-Index ≥ 70%
  • age ≥ 18 years

Exclusion Criteria

  • androgen deprivation therapy
  • lymphatic spread
  • macroscopic tumor/ R2
  • stage IV (M1)
  • previous irradiation

Arms & Interventions

70.0/ 2.0 Gray (RBE)

Normofractionated radiotherapy with photons (70.0/ 2.0 Gray)

Intervention: Normofractionated radiotherapy with photons

57.0/ 3.0 Gray (RBE)

Hypofractionated radiotherapy with photons (57.0/ 3.0 Gray)

Intervention: Hypofractionated radiotherapy with photons

57.0/ 3.0 (RBE)

Hypofractionated radiotherapy with protons (57.0/ 3.0 Gray relative biological effectiveness \[RBE\]).

Intervention: Hypofractionated radiotherapy with protons

Outcomes

Primary Outcomes

Quality of life (prostate-associated, 12 weeks vs baseline)

Time Frame: 12 weeks

The primary objective of the present trial is to show a Change in the bowel symptoms according to scores on the EORTC QLQ-PR25 questionaire after proton therapy compared to photon irradiation (week 12 vs. baseline).

Secondary Outcomes

  • biochemical progression-free survival (bPFS)(5 years after baseline)
  • overall survival (OS)(5 years after baseline)
  • Toxicity acc. to NCI CTCAE V 5.0 after 2 and 5 years(2 and 5 years after baseline)
  • Quality of life (general and prostate-associated, 2 years and 5 years vs. baseline)(2 and 5 years after baseline)

Study Sites (1)

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