MCRPC study: Gedatolisib vs Darolutamide
Official title Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT06190899
What this study is testing
What is Gedatolisib?
An investigational oral medicine being studied for metastatic castration‑resistant prostate cancer. It is designed to inhibit PI3K and mTOR signaling pathways.
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 study aims to find the safest dose and see if the drug combo shows early signs of working in men with metastatic castration‑resistant prostate cancer.
- Who it's for
- Men who have prostate cancer that has spread and no longer responds to hormone therapy.
- What's involved
- Participants will receive the two drugs together, have regular clinic visits, and undergo blood tests and scans to monitor safety and drug levels.
- Time commitment
- The study lasts about 12 weeks of treatment with follow‑up visits every 4 weeks, and participants may stay in the study longer if they continue to receive the drug.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Adult males ≥18 years of age
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without a small cell component and with \<10% neuroendocrine...
- people must have metastatic castration-resistant prostate cancer (mCRPC
- Metastatic disease identified by conventional imaging: computed tomography (CT), magnetic resonance imaging (MRI), or technetium 99m-methyl...
- Progressive mCRPC based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with modifications as specified in Prostate Cancer Working...
You likely can't join if
- History of malignancies other than adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease...
- Adenocarcinoma of the prostate with a small cell component, and with ≥10% neuroendocrine type cells
- Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (AKT) inhibitor, or a mechanistic target of rapamycin (mTOR)...
- Prior treatment with chemotherapy or radiopharmaceutical therapy for mCRPC (except prior chemotherapy plus ADT for castration-sensitive disease...
- people with uncontrolled type 1 or type 2 diabetes 9\. Known and untreated, or active, brain or leptomeningeal metastases.
See the full eligibility criteria
- Adult males ≥18 years of age
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without a small cell component and with \<10% neuroendocrine type cells
- people must have metastatic castration-resistant prostate cancer (mCRPC; i.e., developed progression of metastases following surgical castration or during medical androgen ablation therapy)
- Metastatic disease identified by conventional imaging: computed tomography (CT), magnetic resonance imaging (MRI), or technetium 99m-methyl diphosphonate (99mTc-MDP) bone scintigraphy.
- Progressive mCRPC based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with modifications as specified in Prostate Cancer Working Group 3 (PCWG3) criteria as defined by at least one of the following...
- Continued primary androgen deprivation with luteinizing hormone-releasing hormone (LHRH) analog (agonist or antagonist) if the subject has not undergone bilateral orchiectomy
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤1
- Progression during treatment with one next-generation androgen receptor signaling inhibitor for metastatic disease (e.g., abiraterone, enzalutamide, apalutamide, darolutamide)
- Completion of prior treatment with an androgen receptor inhibitor (ARi) ≥4 weeks before the first dose of the study drug
- At least 2 weeks beyond treatment with a targeted therapy or major surgery and at least 3 weeks beyond any other systemic anticancer therapy and/or radiation therapy, and resolution of all toxicities related to prior...
- Adequate bone marrow, hepatic, renal and coagulation function
- History of malignancies other than adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for ≥3 years
- Adenocarcinoma of the prostate with a small cell component, and with ≥10% neuroendocrine type cells
- Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (AKT) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor
- Prior treatment with chemotherapy or radiopharmaceutical therapy for mCRPC (except prior chemotherapy plus ADT for castration-sensitive disease, including docetaxel plus darolutamide).
- people with uncontrolled type 1 or type 2 diabetes 9\. Known and untreated, or active, brain or leptomeningeal metastases.
The study team makes the final eligibility decision.
Where it is enrolling
- Detroit, Michigan, United States
- Barcelona, Spain
- Madrid, Spain
- Sutton, United Kingdom
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, but 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Detroit, Michigan, United States; Barcelona, Spain; Madrid, Spain; Sutton, United Kingdom. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.