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

Last updated: May 7, 2025
Sponsor: EBG MedAustron GmbH
Overall Status: Terminated

Phase

N/A

Condition

Prostate Cancer

Prostate Disorders

Prostate Cancer, Early, Recurrent

Treatment

kV x-ray images

Conebeam CT

EPIC questionnaire

Clinical Study ID

NCT03740191
PRLI-MA-012016
PRLI
  • Ages > 18
  • Male

Study Summary

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

Eligibility Criteria

Inclusion

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 MRIscan)

  • Any patient with lymph nodes > 1.0 cm maximum diameter requires further studies toaddress eligibility. Positron emission tomography (PET)-CT is recommended for lymphnodes > 1.0 cm. Positive PET-CT indicates malignant involvement. Hence, the patientwill be staged as "high-risk" and therefore declared ineligible for studyparticipation. Negative PET-CT in lymph nodes 1.0-1,5 cm indicates non-involvementand thus eligibility. Negative PET-CT in lymph nodes > 1.5 cm is equivocal andrequires 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 studyentry.

  • 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 forurinary retention may be included.

Exclusion

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 theskin in situ) if not controlled within last two years.

Study Design

Total Participants: 5
Treatment Group(s): 3
Primary Treatment: kV x-ray images
Phase:
Study Start date:
July 03, 2018
Estimated Completion Date:
March 14, 2025

Study 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.

Connect with a study center

  • EBG MedAustron GmbH

    Wiener Neustadt, Niederösterreich 2700
    Austria

    Site Not Available

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