SBRT in 4 Fractions for Prostate Cancer
Phase I-II Study of High Dose SBRT in 4 Fractions for Intermediate Risk Prostate Cancer
1 other identifier
interventional
33
0 countries
N/A
Brief Summary
This is a prospective multicentric phase-I-II pilot feasibility study. The main objective is to study early and late side effects of hypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be \[ 4 x 9.5 Gy = 38 Gy \] delivered in 5 alternative days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Jun 2013
Typical duration for not_applicable prostate-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2018
CompletedFirst Submitted
Initial submission to the registry
February 14, 2019
CompletedFirst Posted
Study publicly available on registry
March 13, 2019
CompletedMarch 13, 2019
March 1, 2019
4.9 years
February 14, 2019
March 11, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Toxicity assessment of 4 fractions SBRT in selected intermediate risk prostate cancer patients.
Toxicity assessment: The presence and grading (CTAE v3/ EORTC-RTOG) of adverse events will be recorded.
up to 5 years
Tumour response to local radiation therapy by assessing freedom from biochemical failure.
Tumour response is evaluated on ASTRO DEFINITION of PSA relapse (+2 from Nadir of PSA).
up to 5 years
Study Arms (1)
SBRT in 4 fraction
EXPERIMENTALSelected intermediate risk prostate cancer patients treated with 4 fraction SBRT
Interventions
hypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be \[ 4 x 9.5 Gy = 38 Gy \] delivered in 5 alternative days, corresponding to an NTD2 between 95 and 119 Gy for an α/β estimate between 3 and 1.5 Gy.
Eligibility Criteria
You may qualify if:
- Age ≤ 85years.
- WHO performance status ≤ 2.
- PSA\>10 and ≤ 20 ng/ml or Gleason Score 7 or T2a-T2c.
- Histologically proven prostate adenocarcinoma
- No pathologic lymph nodes on CT/ MRI scan.
- No distant metastases.
- No previous prostate surgery other than TURP (at least 6 weeks interval before initiation of RT).
- No malignant tumours in the previous 5 years.
- IPSS 0-7.
- Combined HT according to risk factors.
- Informed consent.
You may not qualify if:
- Prostate size greater than 60cc.
- Previous TURP less than 6 weeks before radiotherapy.
- Previous prostate surgery other than TURP.
- Diabetes \*.
- Use of anticoagulants drugs \*.
- Chronic inflammatory bowel disease \*.
- Previous pelvic irradiation.
- Inability to obtain written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Clinical Trial Department
Study Record Dates
First Submitted
February 14, 2019
First Posted
March 13, 2019
Study Start
June 12, 2013
Primary Completion
May 23, 2018
Study Completion
May 23, 2018
Last Updated
March 13, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share