Prostate Cancer
Conditions
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.
Interventions
RADIATIONHypofractionated radiotherapy with photons
hypofractionated radiotherapy with photons (total dose 57.0 Gray in 19 fractions)
RADIATIONHypofractionated radiotherapy with protons
hypofractionated radiotherapy with protons (total dose 57.0 Gray relative biological effectiveness (RBE) in 19 fractions)
RADIATIONNormofractionated radiotherapy with photons
normofractionated radiotherapy with photons (total dose 70.0 Gray in 35 fractions)
Sponsors
University Hospital Heidelberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (prostate-associated, 12 weeks vs baseline) | 12 weeks | The primary objective of the present trial is to show a Change in the bowel symptoms according to scores on the EORTC QLQ-PR25 questionaire after proton therapy compared to photon irradiation (week 12 vs. baseline). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| biochemical progression-free survival (bPFS) | 5 years after baseline | non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to biochemical progression-free survival (bPFS) |
| overall survival (OS) | 5 years after baseline | non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to overall survival (OS) |
| Toxicity acc. to NCI CTCAE V 5.0 after 2 and 5 years | 2 and 5 years after baseline | non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to toxicity |
| Quality of life (general and prostate-associated, 2 years and 5 years vs. baseline) | 2 and 5 years after baseline | non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to changes in the scores of quality of life based on the EORTC QLQ-C30 questionaire |
Countries
Germany
Contacts
CONTACTJuergen Debus
PRINCIPAL_INVESTIGATORJuergen Debus
University Hospital Heidelberg
Outcome results
None listed