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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Heidelberg
Coordinator of this site? Confirm its status
HeidelbergGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.