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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

Organizational Data

DRKS-ID:
DRKS00011912
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2017-03-23
Last update in DRKS:
2023-01-19
Registration type:
Prospective

Acronym/abbreviation of the study

HypoPros I

URL of the study

No Entry

Brief summary in lay language

Radiotherapy is an established treatment option in carcinoma of the prostate. Intensity-modulated, hypofractionated radiotherapy with protons represents a treatment option. The basic procedure is similar compared to conventional radiation. The difference is the number and intensity of dose per daily radiation fraction. Whereas in conventional radiotherapy patients were treated seven to eight weeks, five days a week (35-40 day in total) with a daily dose of 1.8-2 Gy, patients of the HypoPros I-trail were only treated 20 days in total (even 5 days a week) with a higher single dose (3 Gy per day). The aim of the HypoPros I study is to investigate effectivity and tolerance of this radiotherapy.

Brief summary in scientific language

This study is to show that an intensity-modulated, hypofractionated radiotherapy with protons (20 x 3 Gy) is tolerated and effective in patients with carcinoma of the prostate (moderate to high risk profile, locally advanced carcinoma of the prostate).

Health condition or problem studied

ICD10:
C61 - Malignant neoplasm of prostate
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 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 therapy.

Endpoints

Primary outcome:
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:
- 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

Study Design

Purpose:
Treatment
Allocation:
N/A (single arm study)
Control:
  • Uncontrolled/single arm
Phase:
II
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Single (group)
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center Klinik für Partikeltherapie, Westdeutsches Protonentherapiezentrum Essen (WPE) Essen

Recruitment period and number of participants

Planned study start date:
2017-05-01
Actual study start date:
2017-07-20
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
130
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
Male
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional 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

Addresses

Primary Sponsor

Westdeutsches Protonentherapiezentrum Essen (WPE)
Hufelandstr. 55
45147 Essen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Westdeutsches Protonentherapiezentrum Essen (WPE)
Dr. Dirk Geismar
Hufelandstr. 55
45147 Essen
Germany
Telephone:
0201/723 6612
Fax:
0201/723 5255
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Westdeutsches Protonentherapiezentrum Essen (WPE)
Dr. Sabine Frisch
Hufelandstr. 55
45147 Essen
Germany
Telephone:
0201/723 6609
Fax:
0201/723 5255
Contact per E-Mail
URL:
No Entry

Principal Investigator

Westdeutsches Protonentherapiezentrum Essen (WPE)
Dr. Dirk Geismar
Hufelandstr. 55
45147 Essen
Germany
Telephone:
0201/723 6612
Fax:
0201/723 5255
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Westdeutsches Protonentherapiezentrum Essen (WPE)
Hufelandstr. 55
45147 Essen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
Robert-Koch-Str. 9-11
45147 Essen
Germany
Telephone:
+49-201-7233637
Fax:
+49-201-7235837
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2017-02-02
Ethics committee number:
17-7371-BO
Vote of the Ethics Committee:
Approved
Date of the vote:
2017-03-07

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry