Clinical trial NCT03553212: Twice High Dose External Beam Radiotherapy by Image-guided Tomotherapy for Organ-confined Prostate Cancer Treatment Emulating High Dose Radiation (HDR) Brachytherapy
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Adenocarcinoma
Radiotherapy; Complications
Tomotherapy
Keywords: Prostate cancer
organ-confined
external beam Radiotherapy
Image-guided tomotherapy
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 2
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility trial
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: occurrence of Grade ≥3 early GU toxicity
timeFrame: within 3 months after end of Radiotherapy
measure: occurrence of Grade ≥3 early GI toxicity
timeFrame: within 3 months after end of Radiotherapy
Secondary outcomes:
measure: Occurrence of Grade ≥3 Late GU toxicity
timeFrame: more than 6 months after end of Radiotherapy
measure: Evaluation of Prostate Antigen Serum (PSA) failure
timeFrame: up to 8 years
measure: Time to biochemical failure (TTBF)
timeFrame: up to 8 years
measure: Time to progression (TTP)
timeFrame: up to 8 years
measure: Overall Survival (OS)
timeFrame: up to 8 years
measure: Quality of Life (QoL)
timeFrame: before treatment, at 12 and 24 months of follow up
measure: Quality of urinary function
timeFrame: before treatment, at 3, 6, 12 and 24 months of follow up
measure: Quality of erectile function
timeFrame: before treatment, at 3, 6, 12 and 24 months of follow up
Other outcomes:
Locations:
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
state: FC
Study officials:
affiliation: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
name: Sarah Pia Colangione, MD
role: STUDY_CHAIR
References: