The Radium-select Study
68Ga-PSMA-PET/CT and Genomic Alterations for Future Selection of Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) for Radium-223 Treatment.
About This Trial
- This study is looking at whether a newer, advanced imaging scan can help doctors predict how well a targeted radiation treatment works for prostate cancer.
- It is for men whose prostate cancer has spread to at least two areas in their bones and is continuing to grow despite prior therapies.
- To take part, your blood counts must be in a healthy range, and regular scans must show that the cancer has not significantly spread to other organs.
- Before joining, you should know that you will need to continue taking your usual hormone therapy and bone-strengthening medicines throughout the study.
More Information
- Radium-223 is an established radionuclide therapy for patients with metastatic castration resistant prostate cancer (mCRPC) and symptomatic bone metastasis.
- Patients are eligible for this treatment when they have mCRPC and bone metastases; limited extraskeletal lesions (local prostate, lymph nodes <3 cm) on conventional contrast enhanced CT (ceCT) were allowed in the registration trial(1).
- Previous research revealed that extraskeletal disease on ceCT and bone scans correlates with a poor response.
- Meanwhile, 68Ga-PSMA-PET/CT emerged as more sensitive imaging strategy that increases the detection of extraskeletal prostate cancer metastases.
- It is unclear whether these extraskeletal lesions harbour any predictive value in the treatment of mCRPC patients with Radium-223.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study is looking at whether a newer, advanced imaging scan can help doctors predict how well a targeted radiation treatment works for prostate cancer.
Study Details
- Start Date: February 24, 2025
- Lead Sponsor: The Netherlands Cancer Institute
Full Eligibility Criteria
Inclusion Criteria
- Histologically confirmed adenocarcinoma of the prostate.
- Progressive disease after previous treatment defined as a rise in serum (Prostate Specific Antigen) PSA (PCWG3 criteria(22), see appendix 1) and/or progression on conventional imaging (PCWG3).
- A positive bone scan (osteoblastic bone metastases), with at least two metastases.
- Hemoglobin concentration >10 g/dl (6.2 mmol/l) and thrombocytes >100 109/I at baseline.
- Each patient will need to (continue to) receive adequate bone protective agents (e.g. bisphosphonates) and androgen deprivation therapy (ADT) according to current clinical guidelines.
Exclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance score >2
- Life expectancy 3 cm short axis) as identified by conventional imaging (ceCT thorax/abdomen)
Treatments
- Other: 68Ga-PSMA-PET/CT scan