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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Stereotactic Body Radiation Therapy
• Intervention / Treatment: Radiation: SBRT; Radiation: STANDARD OF CARE

Detailed 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).

• Study Type: Interventional
• Enrollment (Anticipated): 266
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonio J Conde Moreno, MD PhD; Phone Number: +34 649039866; Email: antoniojconde@gmail.com
• Study Contact Backup: Name: Fernando López Campos, MD PhD; Phone Number: +34 663158959; Email: fernando_lopez_campos@hotmail.com

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Universitario Ramon y Cajal
    • Contact: Fernando López Campos; Email: flcampos@salud.madrid.org
    • Principal Investigator: Fernando López Campos
    • Principal Investigator: Asunción Hervás Morón
    • Sub-Investigator: Margarita Martín Martín
  • Valencia, Spain
    • Not yet recruiting
    • Hospital Universitari i Politecnic La Fe
    • Contact: Antonio J Conde; Phone Number: 0034649039866 0034649039866; Email: antoniojconde@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional arm; STANDARD OF CARE + SBRT (all metastatic lesions). ADT+ RT to the primary tumor (previously not treated) + Second generation hormonal treatment	Radiation: SBRT; SBRT (all metastatic lesions); Radiation: STANDARD OF CARE; ADT+ RT to the primary tumor (previously not treated) + Second generation hormonal treatment
Active Comparator: Control arm; STANDARD OF CARE. ADT+ RT to the primary tumor (previously not treated) + Second generation hormonal treatment	Radiation: STANDARD OF CARE; ADT+ RT to the primary tumor (previously not treated) + Second generation hormonal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological progression-free survival (rPFS)	based on RECIST 1.1 criteria	An average of two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Time to cytotoxic chemotherapy	Time from trial randomization to start of first cytotoxic chemotherapy	An average of two years
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
Local control	based on RECIST 1.1 criteria	3 years
Time to castration resistance	Defined as the time from trial randomization until castration resistant status	3 years
Time to skeletal-related event	Time from randomization until the occurrence of a skeletal related event (SRE)	An average of two years
Quality of life. FACT-P	FACT-P	Three years after the study completion
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
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

Collaborators and Investigators

• Sponsor: Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic
• Collaborators: Instituto de Investigación en Oncología Radioterápica FEOR (IRAD-FEOR)
• Investigators: Principal Investigator: Antonio J Conde Moreno, MD PhD, Grupo de Investigación Clínica en Oncología Radioterápica; Principal Investigator: Fernando López Campos, MD PhD, Grupo de Investigación Clínica en Oncología Radioterápica; Principal Investigator: Alfonso Gómez-Iturriaga, MD PhD, Grupo de Investigación Clínica en Oncología Radioterápica

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2023
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): January 1, 2027

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Prostate cancer; SBRT; Enzalutamide; Apalutamide; Darolutamide; Oligometastatic prostate cancer; Metastatic hormonosensitive prostate cancer; Second generation hormonal treatments
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Neoplasms
• Other Study ID Numbers: GICOR-SEOR 2-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No