APalutamiAPalutamide and stEReotactic Body Radiation Therapy for Metastatic Prostate Cancer (PERSIAN)

January 29, 2023 updated by: Lorenzo Livi, Azienda Ospedaliero-Universitaria Careggi

APalutamide and stEReotactic Body Radiation Therapy for Low Burden Metastatic Hormone senSItive Prostate Cancer, a rANdomized Trial - PERSIAN

Final results from TITAN trial showed that apalutamide plus ADT improved OS in a population of patients with metastatic hormone sensitive prostate cancer (mHSPC), if compared to ADT alone. However, stereotactic body radiotherapy (SBRT) showed to improve outcomes of oligometastatic patients if compared to systemic therapy alone within modern randomized trial, including a mixed cohort of different pathologies. However, there are no trials specifically exploring the benefit offered by SBRT in oligometastatic mHSPC treated with Apalutamide if compared to Apalutamide alone associated to Androgen deprivation therapy. Thus, a randomized trial was designed to test specifically the hypotesis that SBRT will improve outcome in a selected population of oligometastatic mHSPC treated with Apalutamide and ADT, undergoing baseline staging according to local reimbursability.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Prospective Phase II randomized superiority study, open label, multicentric. Patients with Oligometastatic hormone sensitive prostate cancer defined as presence of ≤ 5 non-visceral metastatic lesions and treated with androgen deprivation treatment associated with Apalutamide will be randomized to receive standard systemic treatment alone or concomitant SBRT on all sites of metastatic disease.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Florence, Italy, 50134
        • AOU Careggi Radiation Oncology Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patients who have signed written informed consent
  • Adult patients ≥ 18 years
  • Oligometastatic hormone sensitive prostate cancer defined as presence of ≤ 5 non-visceral metastatic lesions *, **
  • All lesions must be amenable to SBRT in judgment of treating radiation oncologist ***
  • Patients with metastatic recurrence after previous radical prostatectomy or definitive radiotherapy will be included in the trial, provided that radical approach on prostate is administered
  • Androgen deprivation therapy (ADT) started ≤ 6 months before enrollment
  • Patients should be eligible to Apalutamide treatment

Exclusion Criteria:

  • Presence of visceral disease
  • De novo metastatic disease
  • Any contraindication to the use of Apalutamide
  • Any condition for which, in the opinion of the treating physician, SBRT should not be proposed or could be contraindicated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control
Androgen Deprivation therapy and Apalutamide
Combination product: SBRT on all sites of metastatic disease+Apalutamide
oral Apalutamide 240 mg daily+ stereotactic body radiotherapy on all metastatic sites of disease, administered in 1-8 fractions for a total EQD2 of 50 Gy with an alpha/beta of 10.
EXPERIMENTAL: Treatment
Androgen Deprivation therapy and Apalutamide and SBRT on all sites of metastatic disease
Combination product: SBRT on all sites of metastatic disease+Apalutamide
oral Apalutamide 240 mg daily+ stereotactic body radiotherapy on all metastatic sites of disease, administered in 1-8 fractions for a total EQD2 of 50 Gy with an alpha/beta of 10.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete biochemical response
Time Frame: 6 months after treatment start.
Rate of patients with complete biochemical response (PSA < 0.2 ng/ml)
6 months after treatment start.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from biochemical progression
Time Frame: 2 years after treatment
Biochemical progression defined according to Prostate Cancer Working Group Criteria
2 years after treatment
Freedom from radiological progression
Time Frame: 2 years after treatment
radiological progression defined according to Prostate Cancer Working Group Criteria
2 years after treatment
Rate of adverse events
Time Frame: 2 years after treatment
measured according to Common Terminology Criteria for Adverse Events
2 years after treatment
Overall Survival
Time Frame: 2 years after treatment
Time between randomization and death from any cause
2 years after treatment
Cancer Specific Survival
Time Frame: 2 years after treatment
Time between randomization and death from prostate cancer
2 years after treatment
Health related quality of life
Time Frame: 2 years after treatment
Measured with European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire.
2 years after treatment
Health related quality of life
Time Frame: 2 years after treatment
Measured with EORTC QLQ-PR25 questionnaire
2 years after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria Careggi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 11, 2023

Primary Completion (ANTICIPATED)

September 11, 2024

Study Completion (ANTICIPATED)

March 11, 2025

Study Registration Dates

First Submitted

January 20, 2023

First Submitted That Met QC Criteria

January 29, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

January 29, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PERSIAN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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