Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies

Study Overview
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Brief Summary
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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.

Official Title
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Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Hypofractionated radiotherapy with photons
* Radiation: Hypofractionated radiotherapy with protons
* Radiation: Normofractionated radiotherapy with photons


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (prostate-associated, 12 weeks vs baseline) | 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) | non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to biochemical progression-free survival (bPFS) | 5 years after baseline | 
| overall survival (OS) | 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 | 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) | 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) | 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 |