Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies
Overview
- Phase
- Not Applicable
- Intervention
- Normofractionated radiotherapy with photons
- Conditions
- Prostate Cancer
- Sponsor
- University Hospital Heidelberg
- Enrollment
- 897
- Locations
- 1
- Primary Endpoint
- Quality of life (prostate-associated, 12 weeks vs baseline)
- Status
- Recruiting
- Last Updated
- last month
Overview
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.
Investigators
Juergen Debus
Principal Investigator
University Hospital Heidelberg
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
Arms & Interventions
70.0/ 2.0 Gray (RBE)
Normofractionated radiotherapy with photons (70.0/ 2.0 Gray)
Intervention: Normofractionated radiotherapy with photons
57.0/ 3.0 Gray (RBE)
Hypofractionated radiotherapy with photons (57.0/ 3.0 Gray)
Intervention: Hypofractionated radiotherapy with photons
57.0/ 3.0 (RBE)
Hypofractionated radiotherapy with protons (57.0/ 3.0 Gray relative biological effectiveness \[RBE\]).
Intervention: Hypofractionated radiotherapy with protons
Outcomes
Primary Outcomes
Quality of life (prostate-associated, 12 weeks vs baseline)
Time Frame: 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 Outcomes
- biochemical progression-free survival (bPFS)(5 years after baseline)
- overall survival (OS)(5 years after baseline)
- Toxicity acc. to NCI CTCAE V 5.0 after 2 and 5 years(2 and 5 years after baseline)
- Quality of life (general and prostate-associated, 2 years and 5 years vs. baseline)(2 and 5 years after baseline)