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New treatment option for Oligometastatic Prostate Cancer
Official title Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy
ClinicalTrials.gov ID: NCT05560659
What this study is testing
What is 177Lu-PSMA?
177Lu-PSMA is an investigational medicine, being studied as a potential treatment for oligometastatic prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of this study is to assess the progression free survival (PFS) of SABR alone and SABR + 177Lu-prostate-specific membrane antigen (PSMA) in patients with oligometastatic prostate cancer undergoing PSMA positron emission tomography (PET) staging.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Male aged 18 years or older at screening
- Patient has provided written informed consent
- Histologically confirmed prostate adenocarcinoma w
- Prior definitive treatment of the primary with either curative intent radiotherapy and/or surgery
- Patient has 1-5 sites of nodal or bony metastases on 68Ga-PSMA or 18F-DCFPyL PET/CT
You likely can't join if
- Prior systemic therapy for metastatic prostate cancer. Prior ADT is allowed but ADT within 6 months of screening for the study is not allowed. If...
- Any visceral (AJCCC M1c) metastases
- Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with...
- Has a known additional malignancy that is progressing or required active treatment in the last 2 years Note: Basal cell carcinoma of the skin...
See the full eligibility criteria
- Male aged 18 years or older at screening
- Patient has provided written informed consent
- Histologically confirmed prostate adenocarcinoma w
- Prior definitive treatment of the primary with either curative intent radiotherapy and/or surgery
- Patient has 1-5 sites of nodal or bony metastases on 68Ga-PSMA or 18F-DCFPyL PET/CT
- Adequate haematological function as defined by:
- Absolute neutrophil count (ANC) ≥1.5 x 109/L
- Platelet count \>150x 109/L
- Haemoglobin ≥100 g/L
- Creatinine Clearance ≥ 40mL/min (Cockcroft-Gault formula)
- Assessed as suitable for SABR by a radiation oncologist
- Patients must agree to use an adequate method of contraception
- Have a performance status of 0-1 on the ECOG Performance Scale
- Prior systemic therapy for metastatic prostate cancer. Prior ADT is allowed but ADT within 6 months of screening for the study is not allowed. If patients have received prior ADT, serum testosterone levels must be above...
- Any visceral (AJCCC M1c) metastases
- Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is...
- Has a known additional malignancy that is progressing or required active treatment in the last 2 years Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or carcinoma...
The study team makes the final eligibility decision.
Where it's taking place
- St Leonards, New South Wales, Australia
- Melbourne, Victoria, Australia
- Tel Aviv, Israel
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 study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Leonards, New South Wales, Australia; Melbourne, Victoria, Australia; Tel Aviv, Israel. 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.