Back to resultsSpot-Scanning Based Hypofractionated Proton Therapy for Low and Intermediate Risk Prostate Cancer
Primary Purpose
Low Risk Prostate Cancer, Intermediate Risk Prostate Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
EPIC questionnaire
kV x-ray images
Conebeam CT
Sponsored by
About this trial
This is an interventional other trial for Low Risk Prostate Cancer
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.
Sites / Locations
- EBG MedAustron GmbHRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Proton Therapy of Prostate Cancer
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Determination of the intra-fraction target movement using planar kilovoltage (kV) x-ray Imaging 5x/week or at each day of ion therapy.
Determination of the inter-fraction target and organ at risk movement using Conebeam CT 5x/week or at each day of ion therapy.
Determination of the incidence of gastrointestinal and genitourinary toxicities acute during treatment
Determination of the incidence of gastrointestinal and genitourinary toxicities late at 2 years
Determination of the incidence of gastrointestinal and genitourinary toxicities late at 5 years
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.
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.
Determine disease specific survival at 5 years.
Determine overall survival at 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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03740191
Brief Title
Spot-Scanning Based Hypofractionated Proton Therapy for Low and Intermediate Risk Prostate Cancer
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"
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2018 (Actual)
Primary Completion Date
July 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EBG MedAustron GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Risk Prostate Cancer, Intermediate Risk Prostate Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
297 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Proton Therapy of Prostate Cancer
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
EPIC questionnaire
Intervention Description
The EPIC questionnaire is used to evaluated the Quality of life of the patients including the sexual function.
Intervention Type
Radiation
Intervention Name(s)
kV x-ray images
Intervention Description
After the applied daily fraction, x-ray imaging will be repeated daily to assess for intra-fraction motion of the prostate.
Intervention Type
Radiation
Intervention Name(s)
Conebeam CT
Intervention Description
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.
Primary Outcome Measure Information:
Title
freedom from biochemical failure
Description
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
Time Frame
5 years
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
Determination of the incidence of gastrointestinal and genitourinary toxicities acute during treatment
Time Frame
weekly through treatment completion, Months 3(±1)
Title
Determination of the incidence of gastrointestinal and genitourinary toxicities late at 2 years
Time Frame
Months 24(±2)
Title
Determination of the incidence of gastrointestinal and genitourinary toxicities late at 5 years
Time Frame
Months 60(±4)
Title
Assessment of the quality of life and sexual function following proton therapy.
Description
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.
Time Frame
Baseline, Months 3(±1), 6(±2), 12(±2), 18(±2), 24(±2), 36(±4), 48(±4), 60(±4)
Title
Correlation of adverse events (toxicity), quality of life (QoL) and sexual function with dosevolume histogram parameters adjusted according to actual dose delivered.
Description
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.
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)
Title
Determine disease specific survival at 5 years.
Time Frame
5 years
Title
Determine overall survival at 5 years.
Time Frame
5 years
Title
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.
Description
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).
Time Frame
daily through treatment completion (up to 4 weeks: from 1st day to last day of treatment)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carola Lütgendorf-Caucig, MD MPH MBA
Phone
+43 2622 26 100
Ext
402
Email
carola.luetgendorf-caucig@medaustron.at
First Name & Middle Initial & Last Name or Official Title & Degree
Eugen B. Hug, Uni. Prof. Dr.
Phone
+43 2622 26 100
Ext
102
Email
eugen.hug@medaustron.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petra Georg, Priv. Doz. Dr.
Organizational Affiliation
EBG MedAustron GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
EBG MedAustron GmbH
City
Wiener Neustadt
State/Province
Niederösterreich
ZIP/Postal Code
2700
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petra Georg, Priv. Doz. Dr.
Phone
+43 2622 26 100
Ext
356
Email
petra.georg@medaustron.at
First Name & Middle Initial & Last Name & Degree
Eugen B. Hug, Uni. Prof. Dr.
Phone
+43 2622 26 100
Ext
102
Email
eugen.hug@medaustron.at
12. IPD Sharing Statement
Learn more about this trial
Spot-Scanning Based Hypofractionated Proton Therapy for Low and Intermediate Risk Prostate Cancer
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