Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

897 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-12

Study Completion Date

2029-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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70.0/ 2.0 Gray (RBE)

Normofractionated radiotherapy with photons (70.0/ 2.0 Gray)

Group Type ACTIVE_COMPARATOR

Normofractionated radiotherapy with photons

Intervention Type RADIATION

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

57.0/ 3.0 Gray (RBE)

Hypofractionated radiotherapy with photons (57.0/ 3.0 Gray)

Group Type EXPERIMENTAL

Hypofractionated radiotherapy with photons

Intervention Type RADIATION

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

57.0/ 3.0 (RBE)

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

Group Type EXPERIMENTAL

Hypofractionated radiotherapy with protons

Intervention Type RADIATION

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

Interventions

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Hypofractionated radiotherapy with photons

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

Intervention Type RADIATION

Hypofractionated radiotherapy with protons

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

Intervention Type RADIATION

Normofractionated radiotherapy with photons

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

Intervention Type RADIATION

Eligibility Criteria

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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