Stereotactic hypofractionated radiotherapy with or without hormonal therapy in prostate cancer patients

Phase 1

• Conditions: nfavorable intermediate/high risk prostae cancer patients; Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 21.0Level: LLTClassification code 10036946Term: Prostatic cancerSystem Organ Class: 100000004864

• Registration Number: EUCTR2020-004195-17-IT
• Lead Sponsor: ISTITUTI FISIOTERAPICI OSPITALIERI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 146

Inclusion Criteria

Histologically proven prostate adenocarcinoma
- IR or HR in the NCCN definition
- N0M0 at staging with choline or (preferably) PSMA PET-CT;
- ECOG performance status between 0 and 2;
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 56
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

T3b disease according to the 8th AJCC classification;
- PSA>20 ng/ml at any time point
- Gleason Score of 9 or 10 (Grade Grouping V)
- Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy)
- Previous radiotherapy to the pelvis
- Previous chemotherapy for malignancy in past 5 years
- Impossibility to implant fiducials for tracking purposes
- Impossibility to undergo MRI of the prostate - Contraindication to short term AD - Prostate volume >90cc

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is 3-yr bNED survival. If bNED survival is not significantly different between the two experimental arms, the one without AD will be chosen in a future comparison with the standard of care.;Secondary Objective: Overall survival (OS) at 3 years<br>- Prostate positive biopsy rates at 2 yrs<br>- Metastases free survival at 3 yrs<br>- Cumulative incidence of either GI/GU toxicity at 3 yrs (CTCAE v4.0)<br>- Nadir PSA at various time points<br>- Quality of Life at various time points (EORTC QLQ-C30 & FACT-P)<br>- Erectile function at various time points (IIF-5)<br>- Urinary Continence at various time points (ICIQ-Sf)<br>- IPSS at various time points<br>- Patient satisfaction with treatment at 3 yrs (FACIT-TS-G);Primary end point(s): The primary objective of the study is 3-yr bNED survival.;Timepoint(s) of evaluation of this end point: 3 years after randomization

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: 3 years after randomization