DRKS00011912
Completed
Phase 2
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
Westdeutsches Protonentherapiezentrum Essen (WPE)0 sites133 target enrollmentMarch 23, 2017
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- C61
- Sponsor
- Westdeutsches Protonentherapiezentrum Essen (WPE)
- Enrollment
- 133
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- 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
Outcomes
Primary Outcomes
Not specified
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