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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
Sponsor:
Information provided by (Responsible Party):
Michele Tedeschi, Istituto Clinico Humanitas

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: SBRT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: SBRT in 4 fraction
Selected intermediate risk prostate cancer patients treated with 4 fraction SBRT
Other: 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 :
  1. 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.

  2. 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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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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Responsible Party: Michele Tedeschi, Head of Clinical Trial Department, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT03873090     History of Changes
Other Study ID Numbers: 1136
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases