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PERSIAN: APalutamiAPalutamide and stEReotactic Body Radiation Therapy for Metastatic Prostate Cancer

Sponsor
Azienda Ospedaliero-Universitaria Careggi (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05717660
Collaborator
(none)
180
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: SBRT on all sites of metastatic disease+Apalutamide
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients will be randomized between control arm (Androgen Deprivation therapy and Apalutamide) or treatment arm (Androgen Deprivation therapy and Apalutamide and SBRT on all sites of metastatic disease)Patients will be randomized between control arm (Androgen Deprivation therapy and Apalutamide) or treatment arm (Androgen Deprivation therapy and Apalutamide and SBRT on all sites of metastatic disease)
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
APalutamide and stEReotactic Body Radiation Therapy for Low Burden Metastatic Hormone senSItive Prostate Cancer, a rANdomized Trial - PERSIAN
Anticipated Study Start Date :
Mar 11, 2023
Anticipated Primary Completion Date :
Sep 11, 2024
Anticipated Study Completion Date :
Mar 11, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Complete biochemical response [6 months after treatment start.]

    Rate of patients with complete biochemical response (PSA < 0.2 ng/ml)

Secondary Outcome Measures

  1. Freedom from biochemical progression [2 years after treatment]

    Biochemical progression defined according to Prostate Cancer Working Group Criteria

  2. Freedom from radiological progression [2 years after treatment]

    radiological progression defined according to Prostate Cancer Working Group Criteria

  3. Rate of adverse events [2 years after treatment]

    measured according to Common Terminology Criteria for Adverse Events

  4. Overall Survival [2 years after treatment]

    Time between randomization and death from any cause

  5. Cancer Specific Survival [2 years after treatment]

    Time between randomization and death from prostate cancer

  6. Health related quality of life [2 years after treatment]

    Measured with European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire.

  7. Health related quality of life [2 years after treatment]

    Measured with EORTC QLQ-PR25 questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 AOU Careggi Radiation Oncology Unit Florence Italy 50134

Sponsors and Collaborators

  • Azienda Ospedaliero-Universitaria Careggi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Lorenzo Livi, Full Professor, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier:
NCT05717660
Other Study ID Numbers:
  • PERSIAN
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Prostatic Neoplasms
Hypersensitivity

Study Results

No Results Posted as of Feb 8, 2023