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

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacao Champalimaud

Criteria

Inclusion Criteria:

• Histologic confirmation of adenocarcinoma of the prostate by biopsy confirmed by internal review;

• 68Ga-PSMA or 18F-Choline PET/CT evidence of limited non-visceral (1-3 detectable foci) M1a-b metastases

• All detectable lesions must be considered amenable for SDRT

• Life expectancy > 12 months

• EGOG Performance Status 0-1

• Normal bone marrow functions as defined below: Hemoglobin ≥ 9 g/dl; Absolute Neutrophil count (ANC) ≥1500/ μl; Platelets ≥ 100,000 / μl

• Signed study specific informed consent form

Exclusion Criteria:

• Overt polymetastatic disease (≥ 4 lesions or any visceral lesion) as shown by 68Ga-PSMA or 18F-Choline PET/CT

• Previous radiation therapy for OM deposits

• ECOG Performance status ≥2

• Severe, active co-morbidity

• Significant psychiatric illness