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

NCT03740191 | Terminated

• 2 other identifiers: PRLI-MA-012016PRLI
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Low Risk Prostate Cancer; Intermediate Risk Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• freedom from biochemical failure

  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

  5 years

Secondary Outcomes (10)

• Determination of the intra-fraction target movement using planar kilovoltage (kV) x-ray Imaging 5x/week or at each day of ion therapy.

  daily through treatment completion (up to 4 weeks: from 1st day to last day of treatment)

• Determination of the inter-fraction target and organ at risk movement using Conebeam CT 5x/week or at each day of ion therapy.

  daily through treatment completion (up to 4 weeks: from 1st day to last day of treatment)

• Determination of the incidence of gastrointestinal and genitourinary toxicities acute during treatment

  weekly through treatment completion, Months 3(±1)

• Determination of the incidence of gastrointestinal and genitourinary toxicities late at 2 years

  Months 24(±2)

• Determination of the incidence of gastrointestinal and genitourinary toxicities late at 5 years

  Months 60(±4)

Study Arms (1)

Proton Therapy of Prostate Cancer

OTHER

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

Other: EPIC questionnaire; Radiation: kV x-ray images; Radiation: Conebeam CT

Interventions

EPIC questionnaire OTHER

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

Proton Therapy of Prostate Cancer

kV x-ray images RADIATION

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

Proton Therapy of Prostate Cancer

Conebeam CT 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.

Proton Therapy of Prostate Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EBG MedAustron GmbH: lead

Study Sites (1)

EBG MedAustron GmbH

Wiener Neustadt, Lower Austria, 2700, Austria

Location

Study Officials

• Carola Lütgendorf-Caucig, MD MPH MBA

  EBG MedAustron GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: November 14, 2018
• Study Start: July 3, 2018
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

AU (1)