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Twice High Dose External Beam Radiotherapy by Image-guided Tomotherapy for Organ-confined Prostate Cancer Treatment Emulating High Dose Radiation (HDR) Brachytherapy (THRIP)

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ClinicalTrials.gov Identifier: NCT03553212
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Tracking Information
First Submitted Date  ICMJE May 16, 2018
First Posted Date  ICMJE June 12, 2018
Last Update Posted Date November 9, 2018
Actual Study Start Date  ICMJE October 30, 2018
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2018)
  • occurrence of Grade ≥3 early GU toxicity [ Time Frame: within 3 months after end of Radiotherapy ]
    Early Grade ≥3 GU toxicity measured by Radiation Therapy Oncology Group and European Organisation for Research and Treatment of Cancer (RTOG/EORTC) toxicity scale, using a scoring range from 0 to 5 for, where 0 means an absence of radiation effects and 5 means the effects led to death
  • occurrence of Grade ≥3 early GI toxicity [ Time Frame: within 3 months after end of Radiotherapy ]
    Early Grade ≥3 GI toxicity measured by Radiation Therapy Oncology Group and European Organisation for Research and Treatment of Cancer (RTOG/EORTC) toxicity scale, using a scoring range from 0 to 5 for, where 0 means an absence of radiation effects and 5 means the effects led to death
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03553212 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2018)
  • Occurrence of Grade ≥3 Late GU toxicity [ Time Frame: more than 6 months after end of Radiotherapy ]
    Late Grade ≥3 GU toxicity measured by Radiation Therapy Oncology Group and European Organisation for Research and Treatment of Cancer (RTOG/EORTC) toxicity scale, using a scoring range from 0 to 5 for, where 0 means an absence of radiation effects and 5 means the effects led to death
  • Evaluation of Prostate Antigen Serum (PSA) failure [ Time Frame: up to 8 years ]
    Evaluation of PSA failure is defined according to the Consensus Statement of the American Society of Radiation Oncology (ASTRO) as elevation of PSA levels nadir +2 ng/ml and confirmed by one measurement (Phoenix criterion) or biochemical response through trimestral PSA level evaluation.
  • Time to biochemical failure (TTBF) [ Time Frame: up to 8 years ]
    the time frame from the beginning date of radiation therapy (RT) to the date of PSA failure;
  • Time to progression (TTP) [ Time Frame: up to 8 years ]
    time to progression (TTP), both local and distant defined as time from beginning date of RT to the date of progression of disease, both local and distant, or death whichever came first;
  • Overall Survival (OS) [ Time Frame: up to 8 years ]
    overall survival, defined as the time from the start of treatment to the date of death from any cause, if data will be available, also cause specific survival will be calculated.
  • Quality of Life (QoL) [ Time Frame: before treatment, at 12 and 24 months of follow up ]
    Treatment-related quality of life (QoL) according to the Functional Assessment of Cancer Therapy (FACT-Prostate) questionnaire; which consists of 39 items. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores. Higher scores represent better QoL.
  • Quality of urinary function [ Time Frame: before treatment, at 3, 6, 12 and 24 months of follow up ]
    Urinary functions according to the International Prostate symptom Score (IPSS) questionnaire, which consists of 7 items. Each item is rated on a 0 to 5 score to produce a total I-PSS score with a range from 0 to 35 (asymptomatic to very symptomatic).
  • Quality of erectile function [ Time Frame: before treatment, at 3, 6, 12 and 24 months of follow up ]
    Erectile functions according to International Index of Erectile Function (IEEF-5) questionnaire, which consists of 5 items. Each item is rated on a 1 to 5. High scores represent better erectile function.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Twice High Dose External Beam Radiotherapy by Image-guided Tomotherapy for Organ-confined Prostate Cancer Treatment Emulating High Dose Radiation (HDR) Brachytherapy
Official Title  ICMJE Twice High Dose External Beam Radiotherapy by Image-guided Tomotherapy for Organ-confined Prostate Cancer Treatment Emulating HDR Brachytherapy: Single Institution Feasibility Study
Brief Summary

Feasibility trial of twice high dose radiotherapy using Tomotherapy in patients with organ confined Prostate Cancer histologically proven. The study involves 2 steps:

A) Assessment of safety as proportion of patients with acute ≥G3 Genito-urinary (GU) and Gastro-intestinal (GI) side effects on the first 16 enrolled patients; B) evaluation of primary and secondary objectives on overall patients.

Detailed Description

Twice High dose external beam Radiotherapy by Image-guided tomotherapy for organ-confined Prostate cancer treatment emulating HDR brachytherapy:

Feasibility trial of twice high dose radiotherapy using Tomotherapy in patients with organ confined Prostate Cancer histologically proven. The study involves 2 steps:

A) Assessment of safety as proportion of patients with acute ≥G3 Genito-urinary (GU) and Gastro-intestinal (GI) side effects on the first 16 enrolled patients; B) evaluation of primary and secondary objectives on overall patients. Thirty-one patients will be enrolled, with histologically confirmed very low , low and intermediate risk prostate cancer following the National Comprehensive Cancer Network (NCCN) risk categories guidelines. Patient should not be eligible to prostatectomy or patient's should refuse to undergo surgery.

Prescription dose to the target: 20-23 Gy in 2 fractions on the whole prostate gland +/- seminal vesicles and 24-27 Gy in 2 fractions as simultaneous integrated boost (SIB) on the dominant intraprostatic lesion (DIL) 2 weeks in all.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Feasibility trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Adenocarcinoma
  • Radiotherapy; Complications
  • Tomotherapy
Intervention  ICMJE Radiation: tomotherapy
20-23 Gy in 2 fractions on the whole prostate gland +/- seminal vesicles and 24-27 Gy in 2 fractions as simultaneous integrated boost (SIB) on the dominant intraprostatic lesion (DIL) 2 weeks in all.
Study Arms  ICMJE Experimental: High dose external beam Radiotherapy
Image-guided tomotherapy
Intervention: Radiation: tomotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2018)
31
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2026
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed prostate adenocarcinoma (a diagnostic biopsy with at least 10 cores is needed)
  • Low and intermediate-risk NCCN risk categories: low-risk ( cT1-2a, Gleason Score ≤ 6 PSA <10 ng/ml) and among those with intermediate-risk features (clinical stage T2b-c or GS 7 or PSA 10-20 ng/ml) those patients with favorable ones (a single factor for intermediate risk and GLS 3 + 4 and <50% of biopsy cores containing cancer) will be selected. (30).
  • Age ≥18 years
  • Good performance status , Eastern Cooperative Oncology Group (ECOG) < 2) or Karnofsky performance status (KPS) > 70
  • No previous pelvic RT
  • Patient not eligible to prostatectomy or patient's refusal to undergo surgery.
  • NO previous prostatectomy or TURP
  • Good urinary flow (peak flow ≥ 10 ml/s)
  • Previous ADT is permitted
  • Prostate size ≤ 60 cc
  • International Prostate Symptom Score ≤ 15
  • Male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Nodal involvement or distant metastases (cN1 or cM1)
  • Extracapsular tumor or locally advanced disease (cT3-cT4)
  • IPSS questionnaire > 20
  • Concomitant inflammatory bowel
  • Prior history of chronic prostatitis
  • Prior history of urethral stricture
  • Important systemic diseases or oral anticoagulant therapy ongoing
  • Non-conformity to dose constraints at the treatment planning
  • Other invasive cancer (apart from non-melanoma skin), unless the patient has been free from disease for at least 3 years;
  • Abnormal complete blood count. Any of the following: platelet count less than 75,000/ml, Hb level less than 10 gm/dl, WBC less than 3.5/ml, abnormal renal function tests (creatinine > 1.5), severe renal impairment (GFR less than 30)
  • Placement of pacemakers and metallic vascular clips (all contraindication to performing prostate mpMRI).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Oriana Nanni, PhD +390543739266 oriana.nanni@irst.emr.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03553212
Other Study ID Numbers  ICMJE IRST185.06
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Study Sponsor  ICMJE Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Sarah Pia Colangione, MD Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
PRS Account Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP