Spot-Scanning Based Hypofractionated Proton Therapy for Low and Intermediate Risk Prostate Cancer

  • STATUS
    Recruiting
  • End date
    Dec 19, 2027
  • participants needed
    297
  • sponsor
    EBG MedAustron GmbH
Updated on 7 October 2022

Summary

This prospective study assess the effectiveness and safety of hypofractionated proton radiotherapy in the treatment of intermediate and low risk prostate cancer.

Description

The purpose of this study is to assess the effectiveness and safety of spot-scanning based hypofractionated proton radiotherapy for the treatment of intermediate and low risk prostate cancer. The treatment effectiveness is defined as freedom from biochemical failure. Treatment safety will be documented with acute and late morbidity assessments. Dose volume relationships for late side effects in organs at risk surrounding the prostate will be calculated from the dose volume histogram parameters assessed during treatment planning. Patient assessed Quality of life data including sexual function will be collected to increase our understanding how the reduction of normal tissue irradiation with proton therapy with subsequent decrease in functional impairments will overall affect the patient's life.

Details
Condition Low Risk Prostate Cancer, Intermediate Risk Prostate Cancer
Treatment EPIC questionnaire, kV x-ray images, Conebeam CT
Clinical Study IdentifierNCT03740191
SponsorEBG MedAustron GmbH
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
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