NCT04083937Recruiting
Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies
Source: ClinicalTrials.gov · Last updated 9 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 897 (estimated)
- First submitted
- 7 Jan 2019
- Start date
- 12 Sept 2018
- Primary completion date
- Apr 2028
- Lead sponsor
- University Hospital Heidelberg
- Diseases
- Prostate cancer
- NCT number
- NCT04083937
What you commit to
- Study type: Interventional
- Planned participants: 897
- From 12 Sept 2018 to the primary completion date, Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- androgen deprivation therapy
- previous irradiation
Other
- lymphatic spread
- macroscopic tumor/ R2
- stage IV (M1)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Heidelberg Coordinator of this site? Confirm its status | Heidelberg | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.