NCT04083937 Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies
| NCT ID | NCT04083937 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Heidelberg |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 897 participants |
| Start Date | 2018-09-12 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 897 participants in total. It began in 2018-09-12 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Juergen Debus
PRINCIPAL INVESTIGATOR
University Hospital Heidelberg
Frequently Asked Questions
Who can join the NCT04083937 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04083937 currently recruiting?
Yes, NCT04083937 is actively recruiting participants. Contact the research team at juergen.debus@med.uni-heidelberg.de for enrollment information.
Where is the NCT04083937 trial being conducted?
This trial is being conducted at Heidelberg, Germany.
Who is sponsoring the NCT04083937 clinical trial?
NCT04083937 is sponsored by University Hospital Heidelberg. The principal investigator is Juergen Debus at University Hospital Heidelberg. The trial plans to enroll 897 participants.
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