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New treatment option for Prostate Cancer
Official title START-MET HS Prostate Cancer. : SbrT & Androgen Receptor Therapy METastatic HSPC
ClinicalTrials.gov ID: NCT05209243
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults, men only
You may be able to join 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...
- Informed consent is obtained from the patient.
- Adequate bone-marrow, liver and renal function:
You likely can't join 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...
- 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...
See the full eligibility 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...
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Spain
- Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Spain; Valencia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.