SBRT in 4 Fractions for Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03873090|
Recruitment Status : Completed
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Istituto Clinico Humanitas
Information provided by (Responsible Party):
Michele Tedeschi, Istituto Clinico Humanitas
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: SBRT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I-II Study of High Dose SBRT in 4 Fractions for Intermediate Risk Prostate Cancer|
|Actual Study Start Date :||June 12, 2013|
|Actual Primary Completion Date :||May 23, 2018|
|Actual Study Completion Date :||May 23, 2018|
Experimental: SBRT in 4 fraction
Selected intermediate risk prostate cancer patients treated with 4 fraction SBRT
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.
Primary Outcome Measures :
- Toxicity assessment of 4 fractions SBRT in selected intermediate risk prostate cancer patients. [ Time Frame: up to 5 years ]Toxicity assessment: The presence and grading (CTAE v3/ EORTC-RTOG) of adverse events will be recorded.
- Tumour response to local radiation therapy by assessing freedom from biochemical failure. [ Time Frame: up to 5 years ]Tumour response is evaluated on ASTRO DEFINITION of PSA relapse (+2 from Nadir of PSA).
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