Clinical trial · Interventional
Spot-Scanning Based Hypofractionated Proton Therapy for Low and Intermediate Risk Prostate Cancer
"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"
NCT03740191CI-TRIAL-00089550terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recuitment target for patient enrollment was not met.
Summary
Brief summary (as posted)
This prospective study assess the effectiveness and safety of hypofractionated proton radiotherapy in the treatment of intermediate and low risk prostate cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intermediate Risk Prostate Cancer | — | UNRESOLVED | — |
| Low Risk Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conebeam CT | Radiation | — | UNRESOLVED |
| EPIC questionnaire | Other | — | UNRESOLVED |
| kV x-ray images | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Proton Therapy of Prostate Cancer
- description
- 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
- interventionNames
- Other: EPIC questionnaire
- Radiation: kV x-ray images
- Radiation: Conebeam CT
Primary outcomes (1)
- measure
- freedom from biochemical failure
- timeFrame
- 5 years
- description
- Freedom from biochemical failure outcomes (FFBF) following spot-scanning based, moderately hypofractionated proton therapy will be compared with results of published studies using either similar or standard dose fractionation treatment regimen and using either photon or proton therapy. Determination of e.g., PSA, IPSS, Adverse Events
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Evidence of distant metastases. * Regional lymph node involvement. * International Prostate Symptom Score (IPSS) \> 20 * Hip prosthesis * Second invasive malignancy (except of basal cell and squamous cell carcinoma of the skin in situ) if not controlled within last two years.
References
Publications (0)
Data not yet available
No reference posted for this study.