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Trial record 71 of 1438 for:    prostate cancer AND radiation

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

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ClinicalTrials.gov Identifier: NCT04083937
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Hypofractionated radiotherapy with photons Radiation: Hypofractionated radiotherapy with protons Radiation: Normofractionated radiotherapy with photons Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 897 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies
Actual Study Start Date : September 12, 2018
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : January 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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)




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

  2. overall survival (OS) [ Time Frame: 5 years after baseline ]
    non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to overall survival (OS)

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083937


Contacts
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Contact: Juergen Debus 06221 56 8201 juergen.debus@med.uni-heidelberg.de

Locations
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Germany
University Hospital Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Juergen Debus    06221 56 8201    juergen.debus@med.uni-heidelberg.de   
Contact: Adriane Hommertgen    06221 56 34091    adriane.hommertgen@med.uni-heidelberg.de   
Sponsors and Collaborators
University Hospital Heidelberg

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Responsible Party: Juergen Debus, Principal Investigator, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT04083937     History of Changes
Other Study ID Numbers: PAROS
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases