NCT04031378

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

Status unknown Phase 2 Last updated 24 July 2019

What this trial tests

Phase 2 trial testing Single Dose Radiotherapy (24 Gy) to all detectable lesions, followed by observation in Metastatic Prostate Cancer in 100 participants. Status unknown.

Timeline

1 September 2019

Primary endpoint
1 November 2019

1 November 2022

Quick facts

Lead sponsor	Fundacao Champalimaud
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 September 2019
Primary completion	1 November 2019
Estimated completion	1 November 2022
Sites	1 location across Portugal

Drugs / interventions tested

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

Conditions studied

• Metastatic Prostate Cancer — all drugs for Metastatic Prostate Cancer →
• Prostate Adenocarcinoma — all drugs for Prostate Adenocarcinoma →

Sponsor

Fundacao Champalimaud

Who can join

18 and older, male only, with Metastatic Prostate Cancer or Prostate Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. CSC Radioresistance: A Therapeutic Challenge to Improve Radiotherapy Effectiveness in Cancer.
   Olivares-Urbano MA, Griñán-Lisón C, Marchal JA, Núñez MI. · · 2020 · cited 170× · PMID 32660072 · DOI 10.3390/cells9071651
2. Translating the Immunobiology of SBRT to Novel Therapeutic Combinations for Advanced Prostate Cancer.
   Adorno Febles VR, Blacksburg S, Haas JA, Wise DR. · · 2020 · cited 7× · PMID 32670868 · DOI 10.3389/fonc.2020.00830
3. Node Oligorecurrence in Prostate Cancer: A Challenge.
   Zapatero A, Conde Moreno AJ, Barrado Los Arcos M, Aldave D. · · 2023 · cited 3× · PMID 37627187 · DOI 10.3390/cancers15164159
4. Identification of Key Elements in Prostate Cancer for Ontology Building via a Multidisciplinary Consensus Agreement.
   Moreno A, Solanki AA, Xu T, Lin R, et al · · 2023 · cited 1× · PMID 37370731 · DOI 10.3390/cancers15123121