Phase 2 Prostate Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older who have given their written consent to participate (or whose legal representative has done so on their behalf)
• People who are in reasonably good general health, able to carry out normal daily activities with little or no difficulty (confirm with trial site for specific health score requirements)
• People who have been diagnosed with prostate cancer (a specific type called adenocarcinoma) that is still sensitive to hormone levels, confirmed by a tissue biopsy, with a testosterone level above 100
• People with either newly diagnosed prostate cancer that has spread to five or fewer sites outside the pelvis, or people with a history of prior prostate cancer treatment whose cancer is progressing at five or fewer sites outside the pelvis — in either case, the spread must not involve the brain or liver
• People whose cancer can be measured using a specific type of imaging scan (PERCIST v1.0 criteria)
• People whose cancer at all spread sites is suitable for a high-dose, focused type of radiation treatment
• People whose prostate (and possibly nearby tissue called seminal vesicles) is either already under control or will be treated with focused radiation as part of this trial
• People who have already had a specific type of PET scan (flotufolastat F18) as part of their usual care before starting radiation may use those existing scan results
• People of childbearing potential who agree to use effective contraception or abstain from heterosexual activity during the study and for at least 30 days after the last treatment dose

Who may not be able to join:

• People who are planning to receive hormone-suppressing therapy (ADT) continuously or on and off for the rest of their life
• People who have already received more than 3 months of hormone-suppressing therapy (ADT) before joining the trial
• People who have a medical reason they cannot receive the imaging agent flotufolastat F18
• People with newly diagnosed prostate cancer that has spread to more than five sites outside the pelvis, or that has spread to the brain or liver
• People with a history of prostate cancer that is now progressing at more than five sites outside the pelvis, or that has spread to the brain or liver
• People with HIV infection, unless a treating doctor has confirmed their viral load has been undetectable for at least 6 months on effective treatment
• People with a history of hepatitis B virus (HBV) infection, unless their viral load is undetectable while on suppressive treatment
• People with a history of hepatitis C virus (HCV) infection, unless they have been treated and cured, or are currently on treatment with an undetectable viral load
• People who have had allergic reactions to substances with a similar chemical or biological makeup to the study agent
• People who have a medical reason they cannot undergo a PSMA-PET scan
• People with a serious or uncontrolled illness
• People with another active cancer, if that cancer or its treatment could interfere with the safety or results of this trial (confirm with trial site)
• People who, in the investigator's judgement, have any other condition that would make participation unsafe
• People who, in the investigator's opinion, may not be able to follow all study procedures for any reason, including practical or logistical issues

Important: Always verify eligibility with the trial site directly before applying.