Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hypofractionated radiotherapy with photons, Hypofractionated radiotherapy with protons, Normofractionated radiotherapy with photons.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Radiation Hypofractionated radiotherapy with photons
hypofractionated radiotherapy with photons (total dose 57.0 Gray in 19 fractions) - Radiation Hypofractionated radiotherapy with protons
hypofractionated radiotherapy with protons (total dose 57.0 Gray relative biological effectiveness (RBE) in 19 fractions) - Radiation Normofractionated radiotherapy with photons
normofractionated radiotherapy with photons (total dose 70.0 Gray in 35 fractions)
Primary outcome measures
- Quality of life (prostate-associated, 12 weeks vs baseline) [Time frame: 12 weeks]
Secondary outcome measures (5)
- biochemical progression-free survival (bPFS) [Time frame: 5 years after baseline]
- overall survival (OS) [Time frame: 5 years after baseline]
- Toxicity acc. to NCI CTCAE V 5.0 after 2 and 5 years [Time frame: 2 and 5 years after baseline]
- Quality of life (general and prostate-associated, 2 years and 5 years vs. baseline) [Time frame: 2 and 5 years after baseline]
- Quality of life (general and prostate-associated, 2 years and 5 years vs. baseline) [Time frame: 2 and 5 years after baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- University Hospital Heidelberg — Heidelberg
Identifiers
NCT: NCT04083937 · PAROS