Study record

Short title	START-MET HS Prostate Cancer. : SbrT & Androgen Receptor Therapy METastatic HSPC
Official title	Phase III Study of Stereotactic Body Radiation Therapy (SBRT) Plus Standard of Care in Castration Sensitive Oligometastatic Prostate Cancer Patients.
Acronym	START-MET
ClinicalTrials.gov ID	NCT05209243
Other Study ID Number	GICOR-SEOR 2-21
Status	Recruiting
Fase	Not Applicable
Study type	Interventional
Estimated participants	266
Resultados publicados	No Results Posted

Sponsor and collaborators

Sponsor	Research Institute in Radiation Oncology – Spanish Foundation of Radiation Oncology
Collaborator	FEOR Research Institute in Radiation Oncology (IRAD-FEOR)
Responsible Party	Research Institute in Radiation Oncology – Spanish Foundation of Radiation Oncology

Investigadores

Rol	Nombre	Grupo
Principal Investigator	Antonio J Conde Moreno, MD PhD	Clinical Research Group in Radiation Oncology
Principal Investigator	Fernando López Campos, MD PhD	Clinical Research Group in Radiation Oncology
Principal Investigator	Alfonso Gómez-Iturriaga, MD PhD	Clinical Research Group in Radiation Oncology

Study design

Primary Purpose	Treatment
Allocation	Randomized
Intervention Model	Parallel Assignment
Masking	None (Open Label)
Number of arms	2

Condiciones

• Prostate Cancer
• Stereotactic Body Radiation Therapy

Intervenciones

Tipo	Intervention / treatment	Description
Radiation	SBRT	SBRT — all metastatic lesions
Radiation	STANDARD OF CARE	ADT + RT to the primary tumor, previously not treated, + second generation hormonal treatment

Study arms

Brazo	Tipo	Treatment
Interventional arm	Experimental	STANDARD OF CARE + SBRT, all metastatic lesions. ADT + RT to the primary tumor, previously not treated, + second generation hormonal treatment.
Control arm	Active Comparator	STANDARD OF CARE. ADT + RT to the primary tumor, previously not treated, + second generation hormonal treatment.

Study 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.

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. Patients will be stratified according to prior local treatment, yes/no, or the new imaging technique used, Choline vs PSMA PET/TC.

Outcome measures

Tipo	Outcome Measure	Measure Description	Time Frame
Primary Outcome Measure	Radiological progression-free survival (rPFS)	Based on RECIST 1.1 criteria	An average of two years
Secondary Outcome Measure	Overall survival	Defined as the time from trial randomization to the date of death from any cause.
Secondary Outcome Measure	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
Secondary Outcome Measure	Time to skeletal-related event	Time from randomization until the occurrence of a skeletal related event (SRE).	An average of two years

Study dates

Study Start	2023-01-26
Primary Completion	2025-01
Study Completion	2027-01
Last Update Posted	2023-05-19

Study contacts

Tipo	Nombre	Telephone	Email
Study Contact	Antonio J Conde Moreno, MD PhD	+34 649039866	antoniojconde@gmail.com
Study Contact Backup	Fernando López Campos, MD PhD	+34 663158959	fernando_lopez_campos@hotmail.com

Study sites

Ciudad	Status	Centre	Contacto	Investigadores
Madrid, Spain, 28034	Recruiting	Hospital Universitario Ramón y Cajal	Fernando López Campos 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 Politècnic La Fe	Antonio J Conde 0034649039866 ext 0034649039866 antoniojconde@gmail.com

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/mm³, Neutrophils ≥1500/mm³, platelets ≥1000007mm³. GOT, GPT and Total Bilirrubin ≤1.5*ULN. 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.
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 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.

More information

View official record on ClinicalTrials.gov