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

NCT04031378 | Unknown Phase 2

• 1 other identifier: PRELUDE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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

Metastatic Prostate Cancer; Prostate Adenocarcinoma

Keywords

Single Dose Radiotherapy; Systemic Therapy; IGRT

Outcome Measures

Primary Outcomes (1)

• Number of participants with post-treatment abnormal laboratory values (PSA relapse)

  Comparison of freedom from biochemical relaps over a 5 year time frame

  Participants should be followed continuously, for the duration of 5 years

Study Arms (2)

A

ACTIVE COMPARATOR

Single Dose Radiotherapy (24 Gy) to all detectable lesions, followed by observation using PET/CT imaging studies every 6 months

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

B

EXPERIMENTAL

Single Dose Radiotherapy (24 Gy) to all detectable lesions followed by adjuvant systemic therapy for 6 months stratified by whether disease is castrate-sensitive (mCS-PCa) or castrate-resistant (mCR-PCa)

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

Interventions

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

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

A

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

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

B

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacao Champalimaud: lead

Study Sites (1)

Fundacao Champalimaud

Lisbon, 1400-038, Portugal

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Carlo Greco, M.D.

  Champalimaud Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuela Seixas

CONTACT

+351 965289072; manuela.seixas@fundacaochampalimaud.pt

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: July 24, 2019
• Study Start: September 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2022
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

PT (1)