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

NCT03553212 | Terminated

• 1 other identifier: IRST185.06
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Adenocarcinoma; Radiotherapy; Complications; Tomotherapy

Keywords

Prostate cancer; organ-confined; external beam Radiotherapy; Image-guided tomotherapy

Outcome Measures

Primary Outcomes (2)

• occurrence of Grade ≥3 early GU toxicity

  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

  within 3 months after end of Radiotherapy

• occurrence of Grade ≥3 early GI toxicity

  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

  within 3 months after end of Radiotherapy

Secondary Outcomes (8)

• Occurrence of Grade ≥3 Late GU toxicity

  more than 6 months after end of Radiotherapy

• Evaluation of Prostate Antigen Serum (PSA) failure

  up to 8 years

• Time to biochemical failure (TTBF)

  up to 8 years

• Time to progression (TTP)

  up to 8 years

• Overall Survival (OS)

  up to 8 years

Study Arms (1)

High dose external beam Radiotherapy

EXPERIMENTAL

Image-guided tomotherapy

Radiation: tomotherapy

Interventions

tomotherapy RADIATION

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.

High dose external beam Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead

Study Sites (1)

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

Meldola, FC, 47014, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Sarah Pia Colangione, MD

  Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility trial

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: June 12, 2018
• Study Start: October 30, 2018
• Primary Completion: May 26, 2023
• Study Completion: May 26, 2023
• Last Updated: May 30, 2023

Record last verified: 2023-05

Locations

IT (1)