Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
WPE 08-12
Study information
Scientific title
Radiotherapy with scanning beam protons for locally advanced prostate cancer or localised prostate cancer with risk factors: a phase II non-randomised prospective study
Acronym
ProPro
Study hypothesis
Intensity modulated proton radiotherapy using small size pencil scanning beam is able to deliver highly conformal dose distributions to large target volumes with low integral doses to surrounding tissues. It is the aim of this study to characterise toxicity and effectiveness of this method given at total doses in the upper standard range and with conventional fractionation to target volumes including the prostate, the seminal vesicles, and if the patient denies laparoscopic lymph node sampling, to the pelvic lymph nodes at risk.
As of 12/10/2009, this record has been updated to include extended anticipated start and end dates to this trial due to a delayed start of the clinical treatments at the proton facility. The initial anticipated start and end dates of this trial were as follows:
Initial anticipated start date: 01/10/2009
initial anticipated end date: 01/10/2014
Ethics approval
Local medical ethics committee (Ethik-Kommision of Universitätsklinikum Essen) approved on the 12th May 2009 and the 1st July 2009 (ref: 09-4006)
Study design
Non-randomised prospective phase II study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details found in the interventions section to request a patient information sheet (German only)
Condition
Prostate cancer
Intervention
The patients are separated in different treatment groups according to their pre-registration staging. According to these groups the planning target volumes (PTVs) 1 - 3 will be contoured and treated. There are two ways of proton therapy. Patients who accepted staging lymphadenectomy will receive local treatment of prostate (see treatment group A) and those who refused staging lymphadenectomy will receive loco-regional radiotherapy of the prostate and regional lymph nodes (see treatment group B).
Treatment Group A:
Registered patients, who received a staging lymphadenectomy, are treated in treatment group A.
Prostate: 78 Gy 1.1/39 fractions
Seminal vesicles: 60 Gy 1.1/30 fractions
ADT performed
Treatment Group B:
All patients registered who did not accept the recommended staging lymphadenectomy and who do not refuse androgen deprivation therapy are treated in treatment group B.
Prostate: 78 Gy 1.1/39 fractions
Seminal vesicles: 60 Gy 1.1/30fractions
Regional nodes: 50 Gy 1.1/25 fractions
ADT performed
Treatment Group C:
Patients registered who refuse androgen deprivation or who did not have staging laparoscopy and refuse pelvic node irradiation will be irradiated according to treatment group A. Androgen deprivation is strongly recommended but not mandatory to be treated.
Contact details for patient information sheet:
Dr Dirk Geismar
Westdeutsches Protonentherapiezentrum Essen (WPE)
Hufelandstr. 55
45147 Essen
Germany
Email: dirk.geismar@uk-essen.de
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Incidence of severe late GU and GI toxicity defined as grade 3 - 5 GU and GI complications according to Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) appearing or persisting greater than 120 days after treatment start at 24 months after treatment start (late treatment-related adverse events).
Secondary outcome measures
1. Rate of biochemical failure
2. Overall survival
3. Disease specific survival
4. Rate of clinical progressions and time to clinical progression - local/regional and distant relapse
5. Acute toxicity (GU/GI) greater than or equal to grade 3 (CTC 3.0)
6. Rate of acute grade 2 toxicity (GU/GI) (CTC 3.0)
7. Rate of late grade greater than or equal to 2 GU and GI toxicity
Measured 24 months after treatment start. Acute toxicity is measured until 120 days after treatment start. A follow-up of 2 years after treatment start is required, however, a long term follow-up is recommended. Thus, rate of biochemical failure, overall survival, disease specific survival and rate of late toxicity will possibly be evaluated after 5 years and longer.
Overall trial start date
01/04/2010
Overall trial end date
01/04/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Histologically confirmed prostate cancer with one of the following combinations:
1.1. T3-T4 or Gleason greater than or equal to 8 or prostate specific antigen (PSA) greater than 20 and less than 50 ng/ml
1.2. T1c-T2a and Gleason 7 and PSA greater than 10 and less than or equal to 20 ng/ml
1.3. T2b-T2c and Gleason 7 or PSA greater than 10 and less than or equal to 20 ng/ml
2. Performance status World Health Organization (WHO) less than or equal to 2
3. No evidence of distant metastases. Minimum work-up: a negative bone scan and an actual PSA-value within 2 months prior to registration are required.
4. Negative regional lymph nodes as established by staging lymphadenectomy. For patients denying staging lymphadenectomy, an actual computed tomography (CT) or magnetic resonance imaging (MRI) scan has to be negative for lymph node metastases.
5. Men of child-producing potential must be willing to consent to use effective contraception
6. Aged greater than or equal to 18 years
7. Patients must give study specific informed consent
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
240
Participant exclusion criteria
1. PSA greater than or equal to 50 ng/ml
2. Evidence of distant metastases
3. Pathological proven positive lymph nodes or regional lymph nodes greater than 1.0 cm in the smallest diameter on imaging studies
4. Prior radical prostatectomy or cryosurgery for prostate cancer
5. History of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
6. Prior pelvic radiotherapy or brachytherapy
7. Prior systemic chemotherapy for the study cancer
8. Current or continuing anti-coagulation with Coumadin or equivalent
9. Transurethral resection of the prostate or urethrotomia less than 6 months before radiotherapy
10. Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any cancer
11. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
12. Severe, active co-morbidity, defined as follows:
12.1. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
12.2. Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
12.3. Hip implants
12.4. Major medical or psychiatric condition which in the investigators opinion will prevent completion of the treatment and interfere with follow-up
12.5. Pre-existing of those gastrointestinal (GI) or genitourinary (GU) symptoms of Grade greater than 1 on the Common Toxicity Criteria (CTC) late effect scale, that are considered for the primary end point
Recruitment start date
01/04/2010
Recruitment end date
01/04/2015
Locations
Countries of recruitment
Germany
Trial participating centre
Klinik und Poliklinik für Strahlentherapie
Essen
45122
Germany
Sponsor information
Organisation
University Hospital Essen (Universitatsklinikum Essen) (Germany)
Sponsor details
Hufelandstraße 55
Essen
45147
Germany
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
West German Proton Therapy Centre Essen (Westdeutsches Protonentherapiezentrum Essen [WPE]) gGmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary