Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies

Prostate Cancer Clinical Trial

— PAROS  

Official title:

Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04083937
• Other study ID #: PAROS
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2018
• Est. completion date: January 2029

Study information

• Verified date: January 2024
• Source: University Hospital Heidelberg
• Contact: Juergen Debus
• Phone: 06221 56 8201
• Email: juergen.debus[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 897
• Est. completion date: January 2029
• Est. primary completion date: April 2028
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Hypofractionated radiotherapy with photons
hypofractionated radiotherapy with photons (total dose 57.0 Gray in 19 fractions)
• Hypofractionated radiotherapy with protons
hypofractionated radiotherapy with protons (total dose 57.0 Gray relative biological effectiveness (RBE) in 19 fractions)
• Normofractionated radiotherapy with photons
normofractionated radiotherapy with photons (total dose 70.0 Gray in 35 fractions)

Locations

Country	Name	City	State
Germany	University Hospital Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life (prostate-associated, 12 weeks vs baseline)	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).	12 weeks
Secondary	biochemical progression-free survival (bPFS)	non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to biochemical progression-free survival (bPFS)	5 years after baseline
Secondary	overall survival (OS)	non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to overall survival (OS)	5 years after baseline
Secondary	Toxicity acc. to NCI CTCAE V 5.0 after 2 and 5 years	non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to toxicity	2 and 5 years after baseline
Secondary	Quality of life (general and prostate-associated, 2 years and 5 years vs. 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	2 and 5 years after baseline
Secondary	Quality of life (general and prostate-associated, 2 years and 5 years vs. 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-PR25 questionaire	2 and 5 years after baseline