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

ConditionsProstate CancerStereotactic Body Radiation Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorInstituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SBRT

    Radiation

    SBRT (all metastatic lesions)

  • STANDARD OF CARE

    Radiation

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

Treatment groups

266 Participants
are divided into 2 treatment groups
Group A: Interventional armExperimental treatment 2 interventions
Group B: Control armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Radiological progression-free survival (rPFS)

based on RECIST 1.1 criteria

Time frame
An average of two years

Secondary outcomes

1

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 frame
3 years
2

Time to cytotoxic chemotherapy

Time from trial randomization to start of first cytotoxic chemotherapy

Time frame
An average of two years
3

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

Time frame
An average of two years
4

Local control

based on RECIST 1.1 criteria

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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