START-MET HS Prostate Cancer. : SbrT & Androgen Receptor Therapy METastatic HSPC

Prostate Cancer Clinical Trial

— START-MET  

Official title:

Phase III Study of Stereotactic Body Radiation Therapy (SBRT) Plus Standard of Care in Castration Sensitive Oligometastatic Prostate Cancer Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05209243
• Other study ID #: GICOR-SEOR 2-21
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Stereotactic Body Radiation Therapy

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