68-Ga PSMA11
DrugWill be injected/assessed in line with its FDA label.
Other names: Illucix, Telix
NCT Number: NCT06044857
Sequential cohort evaluation of ideal timing of imaging and treatment spacing to discern maximal PSMA (Prostate specific membrane antigen) PET (Positron Emission Tomography) response (PSMA-11 68Ga, Illucix) for adaptation of dominant intra-prostatic lesion tumor boost dose
Interested in participating?
Request Info18 year–99 year
Male
Interventional
Phase 1
UT Southwestern Medical Center, Dallas, Texas, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-Pathologically confirmed adenocarcinoma of the prostate (within 180 days of registration) of high risk by national comprehensive cancer network (NCCN) criteria as determined by >=cT3a stage (AJCC 8th edition) OR PSA>20ng/mL OR ISUP Grade Group 4-5 (Gleason Grade 8-10).
Age ≥ 18 years.
Exclusion criteria
Prior androgen deprivation therapy (ADT) allowed if <3 month total duration and stopped >=3 months prior to registration with demonstration of non-castrate testosterone recovery (>50ng/dL) and meeting all other inclusion criteria.
Ongoing androgen deprivation therapy (ADT) is allowed if <=60 days total duration AND meeting following criteria:
If GnRH agonist used (e.g. leuprolide), bicalutamide must have been used for at least 30 days +/-14 days from start of GnRH agonist.
All other inclusion criteria.
Will be injected/assessed in line with its FDA label.
Other names: Illucix, Telix
Time frame: Through end of neoadjuvant ADT at 3 months
This study primarily evaluates volume reduction of initial target PSMA-avid dominant intra-prostatic disease after neoadjuvant ADT and during SAbR in differing spacing regimens of SAbR.
Metrics include percent reduction in volume at 3 months of therapy vs initial disease extent of intra-prostatic dominant lesion as identified by PSMA PET.
Contact information is provided by the study sponsor or research team.
Liliana Robles
CONTACT
Sarah Neufeld
CONTACT
University of Texas Southwestern Medical Center
Other
Phase IB Study of Personalized Ultrahypofractionated Stereotactic Ablative Radiotherapy of High Risk PROstate Cancer Guided by PET PSMA (68Ga PMSA-11; Ilucix) Response (PULSAR ProPhet)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05751434
Genital Diseases, Genital Diseases, Male
Los Angeles, California, United States
View Trial DetailsNCT06957691
Adenocarcinoma, Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma
Boston, Massachusetts, United States
View Trial DetailsNCT06238713
Genital Diseases, Genital Diseases, Male
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT06067269
Genital Diseases, Genital Diseases, Male
Los Angeles, California, United States
View Trial Details