Prostate CancerSTART-METNCT05209243
START-MET HS Prostate Cancer. : SbrT & Androgen Receptor Therapy METastatic HSPC
A study testing SBRT in people with Prostate Cancer and Stereotactic Body Radiation Therapy, run by Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Stereotactic Body Radiation Therapy
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 2 sitesSpain
- Study dates
- 26 Jan 2023to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
Fernando López Campos, flcampos@salud.madrid.org
Fernando López Campos
- Not yet recruiting
Hospital Universitari i Politècnic La Fe
Valencia
Antonio J Conde, 0034649039866 ext. 0034649039866, antoniojconde@gmail.com
About this study
Official title: 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.
Read the 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).
- Being tested
- SBRT, STANDARD OF CARE
- Keywords
- SBRT, Prostate cancer, Metastatic hormonosensitive prostate cancer, Second generation hormonal treatments, Oligometastatic prostate cancer, Apalutamide, Enzalutamide, Darolutamide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
SBRT (all metastatic lesions)
STANDARD OF CARERadiation
ADT+ RT to the primary tumor (previously not treated) + Second generation hormonal treatment
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | STANDARD OF CARE + SBRT (all metastatic lesions). ADT+ RT to the primary tumor (previously not treated) + Second generation hormonal treatment Receives: 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 Receives: Radiation: STANDARD OF CARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological progression-free survival (rPFS)
based on RECIST 1.1 criteria
Measured: An average of two years
Secondary outcomes (9)
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.
Measured: 3 years
Time to cytotoxic chemotherapy
Time from trial randomization to start of first cytotoxic chemotherapy
Measured: 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
Measured: An average of two years
Local control
based on RECIST 1.1 criteria
Measured: 3 years
Time to castration resistance
Defined as the time from trial randomization until castration resistant status
Measured: 3 years
Time to skeletal-related event
Time from randomization until the occurrence of a skeletal related event (SRE)
Measured: An average of two years
Quality of life. FACT-P
FACT-P
Measured: 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.
Measured: 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
Measured: Three years after the study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start26 Jan 2023
- Primary completionJan 2025 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio J Conde Moreno, MD PhD, Principal investigator, Grupo de Investigación Clínica en Oncología RadioterápicaFernando López Campos, MD PhD, Principal investigator, Grupo de Investigación Clínica en Oncología RadioterápicaAlfonso Gómez-Iturriaga, MD PhD, Principal investigator, Grupo de Investigación Clínica en Oncología Radioterápica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05209243
- Sponsor's protocol ID
- GICOR-SEOR 2-21
- Acronym
- START-MET
- Status last verified
- May 2023
- First submitted
- 10 Jan 2022
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Stereotactic Body Radiation Therapy (SBRT) Plus Standard of Care in Castration Sensitive Oligometastatic Prostate Cancer Patients.
- ClinicalTrials.gov ID
- NCT05209243
- Acronym / sponsor ID
- START-MET / GICOR-SEOR 2-21
- Keywords
- SBRT, Prostate cancer, Metastatic hormonosensitive prostate cancer, Second generation hormonal treatments, Oligometastatic prostate cancer, Apalutamide, Enzalutamide, Darolutamide
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología RadioterápicUniversity, hospital or other
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Radiation: SBRT, Radiation: STANDARD OF CARESTANDARD OF CARE + SBRT (all metastatic lesions). ADT+ RT to the primary tumor (previously not treated) + Second generation hormonal treatment |
| Control arm | Active comparator | Radiation: STANDARD OF CARESTANDARD OF CARE. ADT+ RT to the primary tumor (previously not treated) + Second generation hormonal treatment |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRTSBRT (all metastatic lesions) | Radiation | Interventional arm |
| STANDARD OF CAREADT+ RT to the primary tumor (previously not treated) + Second generation hormonal treatment | Radiation | Control arm, Interventional arm |
Primary outcome
Radiological progression-free survival (rPFS)
Time frame: An average of two years
based on RECIST 1.1 criteria
9 secondary outcomes
Overall survival
Time frame: 3 years
Time to cytotoxic chemotherapy
Time frame: An average of two years
Time to PSA progression
Time frame: An average of two years
Local control
Time frame: 3 years
Time to castration resistance
Time frame: 3 years
Time to skeletal-related event
Time frame: An average of two years
Quality of life. FACT-P
Time frame: Three years after the study completion
Safety profile
Time frame: Three years after the study completion
Pain. BPI
Time frame: Three years after the study completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonio J Conde Moreno, MD PhD principal investigator
Grupo de Investigación Clínica en Oncología Radioterápica
Fernando López Campos, MD PhD principal investigator
Grupo de Investigación Clínica en Oncología Radioterápica
Alfonso Gómez-Iturriaga, MD PhD principal investigator
Grupo de Investigación Clínica en Oncología Radioterápica
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT in people with Prostate Cancer and Stereotactic Body Radiation Therapy, run by Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio J Conde Moreno, MD PhD (+34 649039866, antoniojconde@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological progression-free survival (rPFS) (time frame: An average of two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.