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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03740191
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
EBG MedAustron GmbH

Tracking Information
First Submitted Date  ICMJE July 9, 2018
First Posted Date  ICMJE November 14, 2018
Last Update Posted Date November 14, 2018
Actual Study Start Date  ICMJE July 3, 2018
Estimated Primary Completion Date July 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2018)
freedom from biochemical failure [ Time Frame: 5 years ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2018)
  • Determination of the intra-fraction target movement using planar kilovoltage (kV) x-ray Imaging 5x/week or at each day of ion therapy. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: weekly through treatment completion, Months 3(±1) ]
  • Determination of the incidence of gastrointestinal and genitourinary toxicities late at 2 years [ Time Frame: Months 24(±2) ]
  • Determination of the incidence of gastrointestinal and genitourinary toxicities late at 5 years [ Time Frame: Months 60(±4) ]
  • Assessment of the quality of life and sexual function following proton therapy. [ Time Frame: Baseline, Months 3(±1), 6(±2), 12(±2), 18(±2), 24(±2), 36(±4), 48(±4), 60(±4) ]
    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.
  • Correlation of adverse events (toxicity), quality of life (QoL) and sexual function with dosevolume histogram parameters adjusted according to actual dose delivered. [ Time Frame: 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) ]
    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.
  • Determine disease specific survival at 5 years. [ Time Frame: 5 years ]
  • Determine overall survival at 5 years. [ Time Frame: 5 years ]
  • 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. [ Time Frame: daily through treatment completion (up to 4 weeks: from 1st day to last day of treatment) ]
    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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spot-Scanning Based Hypofractionated Proton Therapy for Low and Intermediate Risk Prostate Cancer
Official Title  ICMJE "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"
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Low Risk Prostate Cancer
  • Intermediate Risk Prostate Cancer
Intervention  ICMJE
  • Other: EPIC questionnaire
    The EPIC questionnaire is used to evaluated the Quality of life of the patients including the sexual function.
  • Radiation: 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.
  • 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.
Study Arms  ICMJE 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
Interventions:
  • Other: EPIC questionnaire
  • Radiation: kV x-ray images
  • Radiation: Conebeam CT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 12, 2018)
297
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2027
Estimated Primary Completion Date July 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Petra Georg, Priv. Doz. Dr. +43 2622 26 100 ext 356 petra.georg@medaustron.at
Contact: Eugen B. Hug, Uni. Prof. Dr. +43 2622 26 100 ext 102 eugen.hug@medaustron.at
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03740191
Other Study ID Numbers  ICMJE PRLI-MA-012016
PRLI ( Other Identifier: EBG MedAustron GmbH )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party EBG MedAustron GmbH
Study Sponsor  ICMJE EBG MedAustron GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Petra Georg, Priv. Doz. Dr. EBG MedAustron GmbH
PRS Account EBG MedAustron GmbH
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP