Tests shorter radiation courses, with photons or protons, after prostate surgery
Tests shorter, higher-dose radiation after prostate surgery in men with prostate cancer.
Plain-language title generated from the registry record
Registry title: Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies
Key facts
- Where
- Heidelberg, GermanySee the site
Where in Germany
- University Hospital HeidelbergHeidelberg, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital Heidelberg
- Trial code
- NCT04083937
- Record updated
- 9 March 2026
- Original description
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.Read full original descriptionShow less
Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies
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.
Inclusion: 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: androgen deprivation therapy; previous irradiation; lymphatic spread; macroscopic tumor/ R2; stage IV (M1).