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

Prostate Adenocarcinoma Clinical Trial

— THRIP  

Official title:

Twice High Dose External Beam Radiotherapy by Image-guided Tomotherapy for Organ-confined Prostate Cancer Treatment Emulating HDR Brachytherapy: Single Institution Feasibility Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03553212
• Other study ID #: IRST185.06
• Status: Terminated
• Phase: N/A
• Start date: October 30, 2018
• Est. completion date: May 26, 2023

Study information

• Verified date: May 2023
• Source: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 26, 2023
• Est. primary completion date: May 26, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostatic Neoplasms
• Radiotherapy; Complications
• Tomotherapy

Intervention

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.

Locations

Country	Name	City	State
Italy	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)	Meldola	FC

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Occurrence of Grade =3 Late GU toxicity	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	more than 6 months after end of Radiotherapy
Secondary	Evaluation of Prostate Antigen Serum (PSA) failure	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.	up to 8 years
Secondary	Time to biochemical failure (TTBF)	the time frame from the beginning date of radiation therapy (RT) to the date of PSA failure;	up to 8 years
Secondary	Time to progression (TTP)	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;	up to 8 years
Secondary	Overall Survival (OS)	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.	up to 8 years
Secondary	Quality of Life (QoL)	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.	before treatment, at 12 and 24 months of follow up
Secondary	Quality of urinary function	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).	before treatment, at 3, 6, 12 and 24 months of follow up
Secondary	Quality of erectile function	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.	before treatment, at 3, 6, 12 and 24 months of follow up