Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04083937

Studienbeginn:
September 2018

Letztes Update:
05.01.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Prostatic Neoplasms

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Heidelberg

Collaborator:
-

Studienleiter

Juergen Debus
Principal Investigator
University Hospital Heidelberg

Kontakt

Juergen Debus
Kontakt:
Phone: 06221 56 8201
E-Mail: juergen.debus@med.uni-heidelberg.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hospital Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Juergen Debus
Phone: 06221 56 8201
E-Mail: juergen.debus@med.uni-heidelberg.de

Adriane Hommertgen
Phone: 06221 56 8201
E-Mail: adriane.hommertgen@med.uni-heidelberg.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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 outcome:

1. biochemical progression-free survival (bPFS) (Time Frame - 5 years after baseline):
non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to biochemical progression-free survival (bPFS)

2. overall survival (OS) (Time Frame - 5 years after baseline):
non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to overall survival (OS)

3. Toxicity acc. to NCI CTCAE V 5.0 after 2 and 5 years (Time Frame - 2 and 5 years after baseline):
non-inferiority of hypofractionated radiotherapy compared to normofractionated radiotherapy with regard to toxicity

4. Quality of life (general and prostate-associated, 2 years and 5 years vs. baseline) (Time Frame - 2 and 5 years after 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

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

Studien-Arme

Active Comparator: 70.0/ 2.0 Gray (RBE)
Normofractionated radiotherapy with photons (70.0/ 2.0 Gray)
Experimental: 57.0/ 3.0 Gray (RBE)
Hypofractionated radiotherapy with photons (57.0/ 3.0 Gray)
Experimental: 57.0/ 3.0 (RBE)
Hypofractionated radiotherapy with protons (57.0/ 3.0 Gray relative biological effectiveness [RBE]).

Geprüfte Regime

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)

Quelle: ClinicalTrials.gov

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