Intensity-modulated, hypofractionated radiotherapy with scanning beam protons for locally advanced carcinoma of the prostate and localized carcinoma of the prostate with risk factors - a phase II study

Intensity-modulated, hypofractionated radiotherapy with scanning beam protons for locally advanced carcinoma of the prostate and localized carcinoma of the prostate with risk factors - a phase II study - HypoPros I

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011912

Enrollment

130

Registered

2017-03-23

Start date

2017-07-20

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

C61

Interventions

Group 1: Patients with locally advanced carcinoma of the prostate and localized carcinoma of the prostate with risk factors receive an intensity-modulated, hypofractionated (20 x 3 Gy) proton beam the

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - histological proven carcinoma of the prostate (moderate or high risk profile, i.e. PSA > 10 ng/ml and/or Gleason Score = 7 and/or stage T2b-T3b) - performance status according to WHO = 2 - willingness to use contraception - PSA < 50 ng/ml - given informed consent for participation

Exclusion criteria

Exclusion criteria: - Evidence of distant metastasis and metastatic lymph nodes - Indication for irradiation of the pelvic lymphatic drainage - Pre-irradiation in the area of the prostate - Pre-surgery in the area of the prostate or rectum - Transurethral resection (TUR) < 3 months ago - Previous systemic chemotherapy - History of previous tumor disease of another organ (except non-melanoma skin cancer or basal cell carcinoma). Patient has to be tumor-free for 3 years. - Hip implants - Cardiac pacemaker - Medical or psychiatric impairments which impede treatment or late follow-up - Diagnosis of chronic inflammatory bowel disease (colitis ulcerosa, morbus Crohn), even if currently controlled - Pre-existing gastrointestinal and genitourinary toxicity = Grad 2, that is defined as primary endpoint

Design outcomes

Primary

Measure	Time frame
Incidence of severe (= grade 3) gastrointestinal and genitourinary late toxicities (according to CTCAE 4.0) within three years at the end of the proton beam therapy	—

Secondary

Measure	Time frame
- Biochemical failure - Local progress - Distant metastasis - Overall survival - Disease specific survival - Quality of life - Gastrointestinal and genitourinary late toxicities = grade 2 within three years - Gastrointestinal and genitourinary acute toxicities = grade 3 - Gastrointestinal and genitourinary acute toxicities = grade 2 - Erectile dysfunction	—

Countries

Germany

Contacts

Public ContactSabine Frisch

Westdeutsches Protonentherapiezentrum Essen (WPE)

sabine.frisch@uk-essen.de0201/723 6609

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026