ABRUPT: ABlative Radiotherapy (for) Unfavorable Prostate Tumors

Sponsor

University of Milano Bicocca (Other)

Overall Status

Recruiting

CT.gov ID

NCT04831983

Collaborator

(none)

Enrollment

Location

95.5

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Published clinical evidence confirms that a single dose of 24 Gy provides unprecedented long-term local control in primary and metastatic prostate cancer with safe toxicity profiles, provided that exposure of surrounding healthy tissues is critically assessed with fulfillment of strict constraints and dose distribution is accomplished using image guidance and tracking tools. In the present trial, intermediate unfavorable and selected high-risk organ-confined prostate cancer patients will undergo Single Dose Radiation Therapy (SDRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume by means of image-guided volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures. Androgen Deprivation Therapy (ADT) type and duration has been set as per standard of care, in accordance with current recommendations and guidelines.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer

Detailed Description

Patients enrolled in this observational prospective trial will be offered image-guided, volumetric modulated radiotherapy (IGRT-VMAT) in a single session (SDRT) of 21 Gy to the whole gland with a simultaneous boost of 24 Gy to the macroscopic PI-RADS driven (4-5) tumour(s). ADT will be prescribed concomitantly, as per standard of care. A real time non-ionizing prostate monitoring will be used to account for intra-fractional errors. If the dose constraints to the normal tissues are at risk, these will be prioritised over the aimed boost dose. The primary endpoint of the trial is the treatment related toxicity measured by the CTCAE v5.0. Secondary endpoints are quality of life in different domains (sexual, rectal , urinary) and biochemical outcome.

Patients will be followed at one month, then every 3 months for the first 12 months and every 6 months thereafter. Quality of Life will be prospectively evaluated through validated tools (ECOG, EPIC, IIEF-5, IPSS, ICIQ-SF) at various timepoints. Percentage or total mean score will be reported according the questionnaires, whether they grade values in a scale or use descriptive statistics. Kaplan-Meier curve analysis of biochemical relapse free survival (b-RFS) at 2 and 5-year bRFS for all patients will be estimated.

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Single-Dose Image-Guided Radiotherapy (IGRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume for Intermediate Unfavorable and High Risk Prostate Cancer

Actual Study Start Date :

Apr 15, 2021

Anticipated Primary Completion Date :

Apr 1, 2029

Anticipated Study Completion Date :

Apr 1, 2029

Outcome Measures

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0 [60 months]
To assess treatment related gastrointestinal (GI) and genitourinary (GU) toxicity for patients who undergo SD RT with focal boost on dominant lesion(s) for intermediate unfavorable and selected high risk organ-confined prostate cancer.

Secondary Outcome Measures

QUALITY OF LIFE (QOL) assessed by Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire. For each domain minimum symptom score (=0) means best QOL and maximum symptom score (=12) means worst QOL [60 months]
To measure symptom scores for each QOL domain (urinary incontinence, urinary irritative/obstructive, bowel, sexual) after SDRT by EPIC-26 Questionnaire
Number of participants with erectile dysfunction assessed by International Index of Erectile Function Questionnaire ranging from 5 (worst ) to 25 (best) [60 months]
To assess erectile function after SDRT using IIEF 5
Number of participants with voiding symptoms assessed by International Prostatic Symptoms Score (IPSS), ranging from 0 (best) to 35 (worst) [60 months]
To assess voiding symptoms after SDRT using IPSS
Number of participants with urinary incontinence assessed by International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), ranging from 0 (best) to 21 (worst) [60 months]
To assess urinary continence after SDRT using ICIQ-SF
Number of participants with biochemical relapse assessed by PSA (Phoenix definition) [60 months]
To assess biochemical outcome after SDRT using serum PSA levels

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

INCLUSION CRITERIA

Histologically proven prostate adenocarcinoma;
Intermediate and High risk disease, as per the NCCN definition;
N0M0 at staging with standard techniques (Bone Scan and Abdominal CT) or (preferably) Choline or PSMA PET-CT;
ECOG performance status between 0 and 2;
Life expectancy of > 5 years, in the opinion of the investigator;
IPSS score must be ≤ 19 (alpha blockers allowed);

EXCLUSION CRITERIA:

≥T3b disease according to the 8th AJCC classification;
PSA>20 ng/ml at any time point;
Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy);
Previous radiotherapy to the pelvis;
Previous invasive malignancy unless disease free for a minimum of 5 years;
Active Crohn's Disease or Ulcerative Colitis;