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

Phase 2

• Conditions: C61; Malignant neoplasm of prostate

• Registration Number: DRKS00011912
• Lead Sponsor: Westdeutsches Protonentherapiezentrum Essen (WPE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 133

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

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
- Biochemical failure<br>- Local progress<br>- Distant metastasis<br>- Overall survival<br>- Disease specific survival<br>- Quality of life<br>- Gastrointestinal and genitourinary late toxicities = grade 2 within three years<br>- Gastrointestinal and genitourinary acute toxicities = grade 3<br>- Gastrointestinal and genitourinary acute toxicities = grade 2<br>- Erectile dysfunction<br>