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Low Risk Prostate CancerNCT03740191

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

A study testing EPIC questionnaire, kV x-ray images and Conebeam CT in people with Low Risk Prostate Cancer and Intermediate Risk Prostate Cancer, run by EBG MedAustron GmbH at 1 site in Austria.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older, men only
What is being tested?
EPIC questionnaire, kV x-ray images and Conebeam CT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteAustria
Study dates
3 Jul 2018to 14 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • EBG MedAustron GmbH

    Wiener Neustadt, Lower Austria, 2700

Other trials in Austria

About this study

Official title: "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"

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

Read the 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.

Being tested
EPIC questionnaire, kV x-ray images, Conebeam CT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EPIC questionnaireOther

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

  • kV x-ray imagesRadiation

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

  • Conebeam CTRadiation

    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.

Study groups in NCT03740191
Study groupRoleWhat they receive
Proton Therapy of Prostate CancerOtherPatients 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
Receives: Other: EPIC questionnaire; Radiation: kV x-ray images; Radiation: Conebeam CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 5 years

Secondary outcomes (10)

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

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

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

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

  3. Determination of the incidence of gastrointestinal and genitourinary toxicities acute during treatment

    Measured: weekly through treatment completion, Months 3(±1)

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

    Measured: Months 24(±2)

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

    Measured: Months 60(±4)

  6. Assessment of the quality of life and sexual function following proton therapy.

    Change of quality of life and sexual function from Baseline following proton therapy. The Prostate cancer-specific Health-Related Quality of Life questionnaire Expanded Prostate Index Composite (EPIC-26) will be used. EPIC is a comprehensive instrument designed to evaluate patient function and bother after prostate cancer treatment. EPIC-26 was developed as a short-form version of the full EPIC. This version contains 26 item and the same 5 domains as the full version of EPIC: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better quality of life.

    Measured: Baseline, Months 3(±1), 6(±2), 12(±2), 18(±2), 24(±2), 36(±4), 48(±4), 60(±4)

  7. Correlation of adverse events (toxicity), quality of life (QoL) and sexual function with dosevolume histogram parameters adjusted according to actual dose delivered.

    Correlation of adverse events (toxicity) (see Determination of the incidence of gastrointestinal and genitourinary toxicities), quality of life (QoL) and sexual function (see Assessment of the quality of life and sexual function) with dosevolume histogram parameters adjusted according to actual dose delivered.

    Measured: Dose volume histogram parameters: Pre-Treatment, Toxicity: Weekly during proton therapy, Months 3(±1), 6(±2), 12(±2), 18(±2), 24(±2), 36(±4), 48(±4), 60(±4), Quality of life: Pre-Treatment, Months 3(±1), 6(±2), 12(±2), 18(±2), 24(±2), 36(±4)

  8. Determine disease specific survival at 5 years.

    Measured: 5 years

  9. Determine overall survival at 5 years.

    Measured: 5 years

  10. Determination of the intra- and inter- mobility of prostate, seminal vesicles and rectum in order to further define and refine planning target volume parameters for future applications.

    Determination of the intra- and inter- mobility of prostate, seminal vesicles and rectum in order to further define and refine planning target volume parameters for future applications by using data assessed by determination of the intra-fraction target movement using planar kV x-ray imaging 5x/week or at each day of ion therapy (see Determination of the intra-fraction target movement using planar kilovoltage (kV) x-ray Imaging 5x/week or at each day of ion therapy) and determination of the inter-fraction target and organ at risk movement using Conebeam CT (see Determination of the inter-fraction target and organ at risk movement using Conebeam CT 5x/week or at each day of ion therapy).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2018
  2. Study start3 Jul 2018
  3. Primary completion14 Mar 2025
  4. Study completion14 Mar 2025

Why it stopped: Recuitment target for patient enrollment was not met.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03740191
Sponsor's protocol ID
PRLI-MA-012016
Other IDs
PRLI
Status last verified
May 2025
First submitted
9 Jul 2018
Last updated
11 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing EPIC questionnaire, kV x-ray images and Conebeam CT in people with Low Risk Prostate Cancer and Intermediate Risk Prostate Cancer, run by EBG MedAustron GmbH at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Recuitment target for patient enrollment was not met.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

freedom from biochemical failure (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03740191.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.

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