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

NCT05209243 | Recruiting

• 1 other identifier: GICOR-SEOR 2-21
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Prostate Cancer; Stereotactic Body Radiation Therapy

Keywords

SBRT; Prostate cancer; Metastatic hormonosensitive prostate cancer; Second generation hormonal treatments; Oligometastatic prostate cancer; Apalutamide; Enzalutamide; Darolutamide

Outcome Measures

Primary Outcomes (1)

• Radiological progression-free survival (rPFS)

  based on RECIST 1.1 criteria

  An average of two years

Secondary Outcomes (9)

• Overall survival

  3 years

• Time to cytotoxic chemotherapy

  An average of two years

• Time to PSA progression

  An average of two years

• Local control

  3 years

• Time to castration resistance

  3 years

Study Arms (2)

Interventional arm

EXPERIMENTAL

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

Radiation: SBRT; Radiation: STANDARD OF CARE

Control arm

ACTIVE COMPARATOR

STANDARD OF CARE. ADT+ RT to the primary tumor (previously not treated) + Second generation hormonal treatment

Radiation: STANDARD OF CARE

Interventions

SBRT RADIATION

SBRT (all metastatic lesions)

Interventional arm

STANDARD OF CARE RADIATION

ADT+ RT to the primary tumor (previously not treated) + Second generation hormonal treatment

Control arm; Interventional arm

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a histological diagnosis of prostate cancer.
• Castration sensitive prostate cancer patients.
• 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.
• Informed consent is obtained from the patient.
• 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

You may not qualify if:

• Lack of a histological diagnosis of prostate cancer.
• Castration resistant prostate cancer patients according to PCWG3\[30\].
• 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.
• Visceral metastases.
• Tumor stage T4 according to AJCC 8th Edition Cancer staging form.
• Prior treatment with docetaxel, second generation hormonal treatments (Apalutamide/Abiraterone+Prednisone/Enzalutamide) or bone antiresorptive therapy.
• Presence of symptoms or signs that are indicative of urgent surgery/radiotherapy as the first treatment for the metastases disease.
• Lesions that require SBRT treatment that exceed critical organ tolerance limits, or do not meet the criteria for the prescription of SBRT techniques used.
• History of another neoplastic pathology which is not a currently controlled with the exception basal cell carcinomas.
• 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.
• Lack of informed consent or the patient's ability to give consent.

Sponsors & Collaborators

• Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic: lead

Study Sites (2)

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Standard of Care

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)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio J Conde Moreno, MD PhD

CONTACT

+34 649039866; antoniojconde@gmail.com

Fernando López Campos, MD PhD

CONTACT

+34 663158959; fernando_lopez_campos@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * 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 Record Dates

• First Submitted: January 10, 2022
• First Posted: January 26, 2022
• Study Start: January 26, 2023
• Primary Completion: January 1, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)