Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies (PAROS)

University Hospital Heidelberg

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Radiation: Hypofractionated radiotherapy with photons; Radiation: Hypofractionated radiotherapy with protons; Radiation: Normofractionated radiotherapy with photons

Study type: Interventional

Funder types: Other

Identifiers

NCT04083937

PAROS

Details and patient eligibility

About

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.

Enrollment: 897 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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897 participants in 3 patient groups

70.0/ 2.0 Gray (RBE)

Active Comparator group

Description:

Normofractionated radiotherapy with photons (70.0/ 2.0 Gray)

Treatment:

Radiation: Normofractionated radiotherapy with photons

57.0/ 3.0 Gray (RBE)

Experimental group

Description:

Hypofractionated radiotherapy with photons (57.0/ 3.0 Gray)

Treatment:

Radiation: Hypofractionated radiotherapy with photons

57.0/ 3.0 (RBE)

Experimental group

Description:

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

Treatment:

Radiation: Hypofractionated radiotherapy with protons