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

NCT ID: NCT03740191

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-03
• Study Completion Date: 2025-03-14

Brief Summary

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

Detailed 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.

Conditions

Low Risk Prostate Cancer; Intermediate Risk Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Proton Therapy of Prostate Cancer

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

Group Type: OTHER

EPIC questionnaire

Intervention Type: OTHER

The EPIC questionnaire is used to evaluated the Quality of life of the patients including the sexual function.

kV x-ray images

Intervention Type: RADIATION

After the applied daily fraction, x-ray imaging will be repeated daily to assess for intra-fraction motion of the prostate.

Conebeam CT

Intervention Type: RADIATION

For the assessment of interfraction target and organs at risk movement. Conebeam CT as soon as it becomes available will be performed 5 x/week or at each day of proton therapy before treatment application.

Interventions

EPIC questionnaire

The EPIC questionnaire is used to evaluated the Quality of life of the patients including the sexual function.

Intervention Type: OTHER

kV x-ray images

After the applied daily fraction, x-ray imaging will be repeated daily to assess for intra-fraction motion of the prostate.

Intervention Type: RADIATION

Conebeam CT

For the assessment of interfraction target and organs at risk movement. Conebeam CT as soon as it becomes available will be performed 5 x/week or at each day of proton therapy before treatment application.

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

EBG MedAustron GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carola Lütgendorf-Caucig, MD MPH MBA

Role: PRINCIPAL_INVESTIGATOR

EBG MedAustron GmbH

Locations

EBG MedAustron GmbH

Wiener Neustadt, Lower Austria, Austria

Countries

Austria

Other Identifiers

PRLI

Identifier Type: OTHER

Identifier Source: secondary_id

PRLI-MA-012016

Identifier Type: -

Identifier Source: org_study_id