Prostate bed irradiation with alternative radio-oncological approaches

Prostate bed irradiation with alternative radio-oncological approaches - PAROS

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00015231

Enrollment

897

Registered

2018-09-27

Start date

2018-09-14

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C61

Interventions

Group 1: photon IMRT normofractionated (35 x 2 Gy) Group 2: photon IMRT hypofractionated (19 x 3 Gy) Group 3: protons hypofractionated (19 x 3 Gy(RBE))

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - histologically confirmed prostate cancer with classification according to the Gleason score and recent PSA-value - Indication for the irradiation of the prostate bed (adjuvant / salvage) after prostatectomy - Karnofsky index = 70% - Age = 18 years - Patient information and written consent - Ability of the patient to consent

Exclusion criteria

Exclusion criteria: - lymphoid metastasis - R2 - Stage IV (distant metastases) - previous radiotherapy in the pelvis - hip total endoprosthesis - Simultaneous participation in another clinical trial that could influence the results of one of the studies

Design outcomes

Primary

Measure	Time frame
The primary endpoint: Hypofractionated Proton radiotherapy improves rectal quality of life (using the bowel symptom subscale of the QLQ PR 25) compared to the two photon arms. This is evaluated on the difference 12 weeks after the beginning of radiotherapy vs. baseline.	—

Secondary

Measure	Time frame
• Non-inferiority of the hypofractionated therapy arms (arm 2 + 3) compared to the standard arm (arm 1) in terms of biochemical progression-free survival (bPFS) after 5 years. To determine the biochemical lack of recurrence, PSA determinations are carried out consecutively. Two consecutive rises above the nadir are considered recurrences. • Overall survival (OS) after 5 years • Quality of life according to EORTC QLQ-C30 after 2 and after 5 years • clinical symptoms and toxicity (including mortality) after NCI CTCAE version 5.0 at 2 (and after 5) years	—

Measure

Time frame

• Non-inferiority of the hypofractionated therapy arms (arm 2 + 3) compared to the standard arm (arm 1) in terms of biochemical progression-free survival (bPFS) after 5 years. To determine the biochemical lack of recurrence, PSA determinations are carried out consecutively. Two consecutive rises above the nadir are considered recurrences. • Overall survival (OS) after 5 years • Quality of life according to EORTC QLQ-C30 after 2 and after 5 years • clinical symptoms and toxicity (including mortality) after NCI CTCAE version 5.0 at 2 (and after 5) years

—

Countries

Germany

Contacts

Public ContactStudienzentrale Heidelberg

Universitätsklinikum HeidelbergAbteilung RadioOnkologie und Strahlentherapie

studien.radonk@med.uni-heidelberg.de06221 56 36318

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026