TerminatedNo phase
Spot-Scanning Based Hypofractionated Proton Therapy for Low and Intermediate Risk Prostate Cancer
Key facts
- Who runs it
- EBG MedAustron GmbH
- Where
- Austria1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 5 people enrolled
- Started
- 3 Jul 2018
- Ended
- 14 Mar 2025
- Type of study
- Interventional
- Treatments tested
- EPIC questionnaire
- kV x-ray images
- Conebeam CT
- Record updated
- 11 May 2025
- Why it stopped
- Recuitment target for patient enrollment was not met.
Who can take part
- Age
- 18 years and older
- Sex
- Men only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- Pathological (histologically) proven diagnosis of prostatic adenocarcinoma
- Clinical stage T1-T2b
- Prostate specific antigen (PSA) ≤ 20 ng/mL
- Gleason Score ≤ 7
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
- Clinically negative lymph nodes evaluated by imaging (pelvic +/- abdominal CT or MRI scan)
- Any patient with lymph nodes > 1.0 cm maximum diameter requires further studies to address eligibility. Positron emission tomography (PET)-CT is recommended for lymph nodes > 1.0 cm. Positive PET-CT indicates malignant involvement. Hence, the patient will be staged as "high-risk" and therefore declared ineligible for study participation. Negative PET-CT in lymph nodes 1.0-1,5 cm indicates non-involvement and thus eligibility. Negative PET-CT in lymph nodes > 1.5 cm is equivocal and requires additional work-up, preferably by biopsy
- Patients must be 18 years of age or older. There is no upper age limit
- Patient must be able to provide study-specific informed consent prior to study entry
- Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC) Questionnaire to assess Quality of Life
- Previously initiated Androgen Deprivation Therapy (ADT) is acceptable
- Patients with history of chronic bowel diseases may be included
- Patients with previous Transurethral Resection of the Prostate (TURP) performed for urinary retention may be included
Who cannot take part
- Prior radiotherapy to the pelvic area
- Prior prostate cancer therapy such as: prostatectomy, cryotherapy or hyperthermia
- Prior systemic therapy (chemotherapy) for prostate cancer
- Concurrent cytotoxic chemotherapy for prostate cancer
- Second invasive malignancy (except of basal cell and squamous cell carcinoma of the skin in situ) if not controlled within last two years
- Evidence of distant metastases
- Regional lymph node involvement
- International Prostate Symptom Score (IPSS) > 20
- Hip prosthesis
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
This prospective study assess the effectiveness and safety of hypofractionated proton radiotherapy in the treatment of intermediate and low risk prostate cancer.
The group in the trial
- Proton Therapy of Prostate CancerOther group
Patients with low and intermediate risk are included. The following interventions are performed: * 'Expanded Prostate Cancer Index Composite' (EPIC) questionnaire * kV x-ray images * Conebeam CT
Treatment: EPIC questionnaire, kV x-ray images, and Conebeam CT
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- "Spot-Scanning Based Hypofractionated Proton Therapy for Low and Intermediate Risk Prostate Cancer" "Hypofraktionierte Protonentherapie Mit Spot-Scanning-Technik Bei Prostatakarzinom Mit Niedrigem Oder Mittlerem Risiko"
- Record updated
- 11 May 2025