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

Primary Purpose

Prostate Cancer, Stereotactic Body Radiation Therapy

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

SBRT

STANDARD OF CARE

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring SBRT, Prostate cancer, Metastatic hormonosensitive prostate cancer, Second generation hormonal treatments, Oligometastatic prostate cancer, Apalutamide, Enzalutamide, Darolutamide

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.
Participation in other clinical trials at the time of inclusion or in the 3 previous months.

Sites / Locations

Hospital Universitario Ramón y CajalRecruiting
Hospital Universitari i Politècnic La Fe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional arm

Control arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Radiological progression-free survival (rPFS)

based on RECIST 1.1 criteria

Secondary Outcome Measures

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.

Time to cytotoxic chemotherapy

Time from trial randomization to start of first cytotoxic chemotherapy

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

Local control

based on RECIST 1.1 criteria

Time to castration resistance

Defined as the time from trial randomization until castration resistant status

Time to skeletal-related event

Time from randomization until the occurrence of a skeletal related event (SRE)

Quality of life. FACT-P

FACT-P

Safety profile

To determine acute and late toxicity due to radiotherapy, scored using the Common Terminology Criteria for Adverse Events (CTCAE) versión 4.3.

Pain. BPI

Evaluate the impact of the treatment on the patient's quality of life using the Brief Pain Inventory (BPI) questionnaire

Full Information

NCT ID

NCT05209243

First Posted

January 10, 2022

Last Updated

May 18, 2023

Sponsor

Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic

1. Study Identification

Unique Protocol Identification Number

NCT05209243

Brief Title

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

Acronym

START-MET

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 26, 2023 (Actual)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Stereotactic Body Radiation Therapy

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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).

Masking

None (Open Label)

Allocation

Randomized

Enrollment

266 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Interventional arm

Arm Type

Experimental

Arm Description

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

Arm Title

Control arm

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

SBRT

Intervention Description

SBRT (all metastatic lesions)

Intervention Type

Radiation

Intervention Name(s)

STANDARD OF CARE

Intervention Description

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

Primary Outcome Measure Information:

Title

Radiological progression-free survival (rPFS)

Description

based on RECIST 1.1 criteria

Time Frame

An average of two years

Secondary Outcome Measure Information:

Title

Overall survival

Description

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.

Time Frame

3 years

Title

Time to cytotoxic chemotherapy

Description

Time from trial randomization to start of first cytotoxic chemotherapy

Time Frame

An average of two years

Title

Time to PSA progression

Description

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

Time Frame

An average of two years

Title

Local control

Description

based on RECIST 1.1 criteria

Time Frame

3 years

Title

Time to castration resistance

Description

Defined as the time from trial randomization until castration resistant status

Time Frame

3 years

Title

Time to skeletal-related event

Description

Time from randomization until the occurrence of a skeletal related event (SRE)

Time Frame

An average of two years

Title

Quality of life. FACT-P

Description

FACT-P

Time Frame

Three years after the study completion

Title

Safety profile

Description

To determine acute and late toxicity due to radiotherapy, scored using the Common Terminology Criteria for Adverse Events (CTCAE) versión 4.3.

Time Frame

Three years after the study completion

Title

Pain. BPI

Description

Evaluate the impact of the treatment on the patient's quality of life using the Brief Pain Inventory (BPI) questionnaire

Time Frame

Three years after the study completion

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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. Participation in other clinical trials at the time of inclusion or in the 3 previous months.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Antonio J Conde Moreno, MD PhD

Phone

+34 649039866

antoniojconde@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Fernando López Campos, MD PhD

Phone

+34 663158959

fernando_lopez_campos@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antonio J Conde Moreno, MD PhD

Organizational Affiliation

Grupo de Investigación Clínica en Oncología Radioterápica

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Fernando López Campos, MD PhD

Organizational Affiliation

Grupo de Investigación Clínica en Oncología Radioterápica

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alfonso Gómez-Iturriaga, MD PhD

Organizational Affiliation

Grupo de Investigación Clínica en Oncología Radioterápica

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitario Ramón y Cajal

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fernando López Campos

flcampos@salud.madrid.org

First Name & Middle Initial & Last Name & Degree

Fernando López Campos

First Name & Middle Initial & Last Name & Degree

Asunción Hervás Morón

First Name & Middle Initial & Last Name & Degree

Margarita Martín Martín

Facility Name

Hospital Universitari i Politècnic La Fe

City

Valencia

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Antonio J Conde

Phone

0034649039866

Ext

0034649039866

antoniojconde@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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