Clinical trial NCT03740191: 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
Overall status: TERMINATED
Phase: NA
Conditions: Low Risk Prostate Cancer
Intermediate Risk Prostate Cancer
Lead sponsor: EBG MedAustron GmbH
Sponsor class: INDUSTRY
First posted: 2018-11-14
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: freedom from biochemical failure
timeFrame: 5 years
Secondary outcomes:
measure: Determination of the intra-fraction target movement using planar kilovoltage (kV) x-ray Imaging 5x/week or at each day of ion therapy.
timeFrame: daily through treatment completion (up to 4 weeks: from 1st day to last day of treatment)
measure: Determination of the inter-fraction target and organ at risk movement using Conebeam CT 5x/week or at each day of ion therapy.
timeFrame: daily through treatment completion (up to 4 weeks: from 1st day to last day of treatment)
measure: Determination of the incidence of gastrointestinal and genitourinary toxicities acute during treatment
timeFrame: weekly through treatment completion, Months 3(±1)
measure: Determination of the incidence of gastrointestinal and genitourinary toxicities late at 2 years
timeFrame: Months 24(±2)
measure: Determination of the incidence of gastrointestinal and genitourinary toxicities late at 5 years
timeFrame: Months 60(±4)
measure: Assessment of the quality of life and sexual function following proton therapy.
timeFrame: Baseline, Months 3(±1), 6(±2), 12(±2), 18(±2), 24(±2), 36(±4), 48(±4), 60(±4)
measure: Correlation of adverse events (toxicity), quality of life (QoL) and sexual function with dosevolume histogram parameters adjusted according to actual dose delivered.
timeFrame: 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)
measure: Determine disease specific survival at 5 years.
timeFrame: 5 years
measure: Determine overall survival at 5 years.
timeFrame: 5 years
measure: 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.
timeFrame: daily through treatment completion (up to 4 weeks: from 1st day to last day of treatment)
Other outcomes:
Locations:
city: Wiener Neustadt
country: Austria
facility: EBG MedAustron GmbH
state: Niederösterreich
Study officials:
affiliation: EBG MedAustron GmbH
name: Carola Lütgendorf-Caucig, MD MPH MBA
role: PRINCIPAL_INVESTIGATOR
References: