Status:
UNKNOWN
Single Dose Radiotherapy (SDRT) With or Without Adjuvant Systemic Therapy for Oligometastatic Prostate Cancer
Lead Sponsor:
Fundacao Champalimaud
Conditions:
Metastatic Prostate Cancer
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 a...
Detailed Description
Since a systemic therapy alone is incapable of permanently ablating metastatic prostate cancer (mPCa) lesions, we have designed this clinical trial to explore whether its combination with radiation ab...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04031378
Start Date
September 1 2019
End Date
November 1 2022
Last Update
July 24 2019
Active Locations (1)
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1
Fundacao Champalimaud
Lisbon, Portugal, 1400-038