Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies (PAROS)

January 4, 2024 updated by: Juergen Debus, University Hospital Heidelberg

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

897

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 70.0/ 2.0 Gray (RBE)
Normofractionated radiotherapy with photons (70.0/ 2.0 Gray)
Radiation: Normofractionated radiotherapy with photons
normofractionated radiotherapy with photons (total dose 70.0 Gray in 35 fractions)
Experimental: 57.0/ 3.0 Gray (RBE)
Hypofractionated radiotherapy with photons (57.0/ 3.0 Gray)
Radiation: Hypofractionated radiotherapy with photons
hypofractionated radiotherapy with photons (total dose 57.0 Gray in 19 fractions)
Experimental: 57.0/ 3.0 (RBE)
Hypofractionated radiotherapy with protons (57.0/ 3.0 Gray relative biological effectiveness [RBE]).
Radiation: Hypofractionated radiotherapy with protons
hypofractionated radiotherapy with protons (total dose 57.0 Gray relative biological effectiveness (RBE) in 19 fractions)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biochemical progression-free survival (bPFS)
Time Frame: 5 years after baseline
non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to biochemical progression-free survival (bPFS)
5 years after baseline
overall survival (OS)
Time Frame: 5 years after baseline
non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to overall survival (OS)
5 years after baseline
Toxicity acc. to NCI CTCAE V 5.0 after 2 and 5 years
Time Frame: 2 and 5 years after baseline
non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to toxicity
2 and 5 years after baseline
Quality of life (general and prostate-associated, 2 years and 5 years vs. baseline)
Time Frame: 2 and 5 years after baseline
non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to changes in the scores of quality of life based on the EORTC QLQ-C30 questionaire
2 and 5 years after baseline
Quality of life (general and prostate-associated, 2 years and 5 years vs. baseline)
Time Frame: 2 and 5 years after baseline
non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to changes in the scores of quality of life based on the EORTC QLQ-PR25 questionaire
2 and 5 years after baseline

Collaborators and Investigators

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

Sponsor

University Hospital Heidelberg

Investigators

  • Principal Investigator: Juergen Debus, University Hospital Heidelberg

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)

September 12, 2018

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

September 9, 2019

First Posted (Actual)

September 10, 2019

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAROS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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