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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05209243
Other study ID # GICOR-SEOR 2-21
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 26, 2023
Est. completion date January 2027

Study information

Verified date May 2023
Source Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic
Contact Antonio J Conde Moreno, MD PhD
Phone +34 649039866
Email antoniojconde@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Phase III study of stereotactic body radiation therapy (SBRT) plus standard of care in castration sensitive oligometastatic prostate cancer patients, defined as androgen deprivation therapy plus radiotherapy to the primary tumor in previously not treated patients and second generation hormonal treatments (Apalutamide/Abiraterone+Prednisone/Enzalutamide) vs androgen deprivation therapy plus radiotherapy to the primary tumor in previously not treated patients plus second generation hormonal treatments, for the treatment of oligometastatic prostate cancer.


Description:

A total of 266 patients with a histological diagnosis of metastatic hormone sensitive prostate cancer, with limited disease (≤ 3 lesions based on CT and Bone Scan and ≤ 5 lesions based on Choline or PSMA PET/TC) at the diagnosis or in an oligorrecurrent stage will be included in the study. Candidates will be first screened for metastatic sites through bone scintigraphy and computerised tomography (CT) scans. Those who meet the ≤3 metastatic sites criteria will be second screened for metastatic sites based on Choline or PSMA PET/TC, which will be used to define the treatment volume of metastatic disease with SBRT/HIGRT and to confirm the oligometastatic status before the inclusion in the study. Once included in the study, patients will be randomize (1:1) to standard of care + SBRT vs standard of care. - Interventional arm: STANDARD OF CARE + SBRT (all metastatic lesions). ADT+ RT to the primary tumor (previously not treated) + Second generation hormonal treatment - Control arm: STANDARD OF CARE. ADT+ RT to the primary tumor (previously not treated) + Second generation hormonal treatment Patients will be stratified according to prior local treatment (yes/no) or the new imaging technique used (Choline vs PSMA PET/TC).


Recruitment information / eligibility

Status Recruiting
Enrollment 266
Est. completion date January 2027
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria: 1. Patients with a histological diagnosis of prostate cancer. 2. Castration sensitive prostate cancer patients. 3. Oligometastatic disease defined as less than or equal 3 lesions based on CT and Bone Scan and less than or equal 5 lesions based on Choline or PSMA PET/TC. Bone metastases (including the spine) or/and lymph nodes metastases. 4. Informed consent is obtained from the patient. 5. Adequate bone-marrow, liver and renal function: - Haemoglobin =10 g/dL, Leucocytes = 2000/mm^3, Neutrophils =1500/mm^3, platelets =1000007mm^3 - GOT, GPT and Total Bilirrubin =1.5*ULN (Upper limit of normality) - Creatinine =1.5*ULN or Creatinine Clearance =50 ml/min^-1 Exclusion Criteria: 1. Lack of a histological diagnosis of prostate cancer. 2. Castration resistant prostate cancer patients according to PCWG3[30]. 3. Metastatic disease defined as greater than or equal 3 lesions based on CT and Bone Scan and greater than or equal 5 lesions based on Choline or PSMA PET/TC. 4. Visceral metastases. 5. Tumor stage T4 according to AJCC 8th Edition Cancer staging form. 6. Prior treatment with docetaxel, second generation hormonal treatments (Apalutamide/Abiraterone+Prednisone/Enzalutamide) or bone antiresorptive therapy. 7. Presence of symptoms or signs that are indicative of urgent surgery/radiotherapy as the first treatment for the metastases disease. 8. Lesions that require SBRT treatment that exceed critical organ tolerance limits, or do not meet the criteria for the prescription of SBRT techniques used. 9. History of another neoplastic pathology which is not a currently controlled with the exception basal cell carcinomas. 10. Presence of a cardiopathy or metabolic disorder that does not recommend the treatment with second generation hormonal treatments, or the presence of inflammatory bowel disease or other pathology that does not recommend the treatment with radiotherapy. 11. Lack of informed consent or the patient's ability to give consent. 12. Participation in other clinical trials at the time of inclusion or in the 3 previous months.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
SBRT
SBRT (all metastatic lesions)
STANDARD OF CARE
ADT+ RT to the primary tumor (previously not treated) + Second generation hormonal treatment

Locations

Country Name City State
Spain Hospital Universitario Ramón y Cajal Madrid
Spain Hospital Universitari i Politècnic La Fe Valencia

Sponsors (1)

Lead Sponsor Collaborator
Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Radiological progression-free survival (rPFS) based on RECIST 1.1 criteria An average of two years
Secondary Overall survival Defined as the time from trial randomization to the date of death from any cause. Patients not experiencing an event will be censored at the last known time they were alive. 3 years
Secondary Time to cytotoxic chemotherapy Time from trial randomization to start of first cytotoxic chemotherapy An average of two years
Secondary Time to PSA progression Counted from the day of randomization to the day of either first recorded biochemical progression[30]. Patients not experiencing a biochemical failure are censored at time of last assessment An average of two years
Secondary Local control based on RECIST 1.1 criteria 3 years
Secondary Time to castration resistance Defined as the time from trial randomization until castration resistant status 3 years
Secondary Time to skeletal-related event Time from randomization until the occurrence of a skeletal related event (SRE) An average of two years
Secondary Quality of life. FACT-P FACT-P Three years after the study completion
Secondary Safety profile To determine acute and late toxicity due to radiotherapy, scored using the Common Terminology Criteria for Adverse Events (CTCAE) versión 4.3. Three years after the study completion
Secondary Pain. BPI Evaluate the impact of the treatment on the patient's quality of life using the Brief Pain Inventory (BPI) questionnaire Three years after the study completion
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