Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies
- Conditions
- Prostate Cancer
- Interventions
- Radiation: Hypofractionated radiotherapy with protonsRadiation: Normofractionated radiotherapy with photonsRadiation: Hypofractionated radiotherapy with photons
- Registration Number
- NCT04083937
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 897
- 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
- androgen deprivation therapy
- lymphatic spread
- macroscopic tumor/ R2
- stage IV (M1)
- previous irradiation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 57.0/ 3.0 (RBE) Hypofractionated radiotherapy with protons Hypofractionated radiotherapy with protons (57.0/ 3.0 Gray relative biological effectiveness \[RBE\]). 70.0/ 2.0 Gray (RBE) Normofractionated radiotherapy with photons Normofractionated radiotherapy with photons (70.0/ 2.0 Gray) 57.0/ 3.0 Gray (RBE) Hypofractionated radiotherapy with photons Hypofractionated radiotherapy with photons (57.0/ 3.0 Gray)
- Primary Outcome Measures
Name Time Method Quality of life (prostate-associated, 12 weeks vs baseline) 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
Name Time Method Quality of life (general and prostate-associated, 2 years and 5 years vs. baseline) 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
biochemical progression-free survival (bPFS) 5 years after baseline non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to biochemical progression-free survival (bPFS)
overall survival (OS) 5 years after baseline non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to overall survival (OS)
Toxicity acc. to NCI CTCAE V 5.0 after 2 and 5 years 2 and 5 years after baseline non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to toxicity
Trial Locations
- Locations (1)
University Hospital Heidelberg
🇩🇪Heidelberg, Germany