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

NCT ID: NCT03553212

Last Updated: 2023-05-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-30
• Study Completion Date: 2023-05-26

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.

Conditions

Prostate Adenocarcinoma; Radiotherapy; Complications; Tomotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High dose external beam Radiotherapy

Image-guided tomotherapy

Group Type: EXPERIMENTAL

tomotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Pia Colangione, MD

Role: STUDY_CHAIR

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

Locations

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

Meldola, FC, Italy

Countries

Italy

Other Identifiers

IRST185.06

Identifier Type: -

Identifier Source: org_study_id