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Single Dose Radiotherapy (SDRT) With or Without Adjuvant Systemic Therapy for Oligometastatic Prostate Cancer

NCT04031378 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-07-24

No results posted yet for this study

Summary

The present study aims to optimize the use of systemic therapy relative to local tumor ablation in a prospective randomized clinical trial and to validate the existence and characterize the clinical and pathology phenotype of oligometastatic (OM) prostate cancer (OM-PCa).

For local tumor ablation we propose to use the novel non-invasive and highly effective technique of Image-Guided Single Dose Radiotherapy (SDRT), which we showed is capable of conferring long-term local relapse-free rates in ≥ 90% of metastatic PCa lesions. Concomitantly, we will develop, validate and implement a diagnostic algorithm for OM-PCa and functionally characterize Prostate Cancer Stem Cells (pCSCs) from human samples to correlate their molecular phenotypes with tumor response to treatment. The long-term aim is to define the indications, standardization of treatment protocols and outcome for OM-PCa. Response assessment will be via local control, metastasis-free survival and overall survival rates. Cases displaying the clinical OM phenotype, as disclosed via long-term disease remission following tumor ablation, will represent the basis to identify the molecular signatures of OM-PCa. These signatures will be used to develop and validate an algorithm to predict the OM phenotype upfront and define the treatment strategy that may lead to cure.

Conditions

Interventions

RADIATION

Single Dose Radiotherapy (24 Gy) to all detectable lesions, followed by observation

SBRT to a single dose of 24 Gy to up to 3 sites

DRUG

Single Dose Radiotherapy (24 Gy) to all detectable lesions followed by adjuvant systemic therapy for 6 months

SBRT 24 Gy to up to 3 nsites, followed by by systemic therapy based on phenotype.

Sponsors & Collaborators

  • Fundacao Champalimaud

    lead OTHER

Principal Investigators

  • Carlo Greco, M.D. · Champalimaud Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2019-11-01
Completion
2022-11-01

Countries

  • Portugal

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04031378 on ClinicalTrials.gov