Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies

NCT04083937 | Recruiting

• 1 other identifier: PAROS
• Study Type: interventional
• Target: 897
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Quality of life (general and prostate-associated, 2 years and 5 years vs. baseline)

  2 and 5 years after baseline

Study Arms (3)

70.0/ 2.0 Gray (RBE)

ACTIVE COMPARATOR

Normofractionated radiotherapy with photons (70.0/ 2.0 Gray)

Radiation: Normofractionated radiotherapy with photons

57.0/ 3.0 Gray (RBE)

EXPERIMENTAL

Hypofractionated radiotherapy with photons (57.0/ 3.0 Gray)

Radiation: Hypofractionated radiotherapy with photons

57.0/ 3.0 (RBE)

EXPERIMENTAL

Hypofractionated radiotherapy with protons (57.0/ 3.0 Gray relative biological effectiveness \[RBE\]).

Radiation: Hypofractionated radiotherapy with protons

Interventions

Hypofractionated radiotherapy with photons RADIATION

hypofractionated radiotherapy with photons (total dose 57.0 Gray in 19 fractions)

57.0/ 3.0 Gray (RBE)

Hypofractionated radiotherapy with protons RADIATION

hypofractionated radiotherapy with protons (total dose 57.0 Gray relative biological effectiveness (RBE) in 19 fractions)

57.0/ 3.0 (RBE)

Normofractionated radiotherapy with photons RADIATION

normofractionated radiotherapy with photons (total dose 70.0 Gray in 35 fractions)

70.0/ 2.0 Gray (RBE)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• androgen deprivation therapy
• lymphatic spread
• macroscopic tumor/ R2
• stage IV (M1)
• previous irradiation

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

University Hospital Heidelberg

Heidelberg, 69120, Germany

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Photons; Protons

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Elementary Particles; Physical Phenomena; Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing; Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons

Study Officials

• Juergen Debus

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juergen Debus

CONTACT

06221 56 8201; juergen.debus@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: September 10, 2019
• Study Start: September 12, 2018
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

DE (1)