Trials Sponsors Conditions Drugs Pricing

Conditions

Prostate Cancer

Keywords

Radioligand Therapy

Outcome Measures

Primary Outcomes (2)

Mean whole body tumor absorbed dose (WB Dose) across all metastatic lesions
The unit density sphere model will be implemented using OLINDA, a second-generation personal computer software for internal dose assessment in nuclear medicine to measure mean dose across all metastatic lesions. This approach uses the three time-point SPECT/CTs to create a whole-body dose map, which can then be segmented. Using OLINDA, the total dose to each tumor will be calculated as the integral of activity over time estimated out to 500 hours. Dose will be calculated in gray (Gy).
Up to 6 months
Median PORTOS score
PORTOS is a gene signature that predicts salvage radiation success. A PORTOS score of zero (called a "low" PORTOS) means it predicts no benefit from salvage radiotherapy. A PORTOS greater than zero (called a "high" PORTOS score) predicts a benefit from salvage radiation.
Up to 6 months

Study Arms (1)

Participants undergoing 177Lu-PSMA-617 treatment

Participants undergoing PSMA targeted radioligand therapy with at least four cycles of treatment planned will undergo the following: SPECT/CTs will be performed 24 hours after the first treatment and after the fourth treatment, a tumor biopsy will be performed prior to the first 177Lu-PSMA radioligand therapy, a blood will be drawn prior to treatment for future research, and an optional tumor biopsy and blood draw for future research, may also be obtained at time of progression.

Procedure: Single-photon emission computed tomographyProcedure: Blood DrawProcedure: Tumor Biopsy

Interventions

Single-photon emission computed tomographyProcedure

Imaging procedure

Also known as: SPECT/CT

Participants undergoing 177Lu-PSMA-617 treatment

Blood DrawProcedure

Blood draw for future research tests (45-60 mL).

Participants undergoing 177Lu-PSMA-617 treatment

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Participants will be selected from patients enrolled on Lutetium based PSMA-RLTs and expected to receiving at least four cycles of PSMA-RLT

You may qualify if:

Initiating treatment with Lutetium based PSMA-targeted RLT.

Sponsors & Collaborators

University of California, San Francisco
Otherlead
Prostate Cancer Foundation
Othercollaborator
National Cancer Institute (NCI)

Study Sites (3)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Johannes Czernin, MDPRINCIPAL INVESTIGATOR

Matthew Rettig, MDPRINCIPAL INVESTIGATOR

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Maya AslamCONTACT415-514-8987 Maya.Aslam@ucsf.edu

Biospecimen

Retention: SAMPLES WITH DNA

Tissue and blood samples will be obtained.

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Blood Specimen CollectionBiopsy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling

Study Officials

Thomas Hope, MD
University of California, San Francisco
PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Aslam

CONTACT

(415) 514-8987 Maya.Aslam@ucsf.edu

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 22, 2022

First Posted

June 28, 2022

Study Start

October 21, 2021

Actual (reported)

Primary Completion

December 31, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Mechanisms of Resistance to PSMA Radioligand Therapy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Participants undergoing 177Lu-PSMA-617 treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Participants undergoing 177Lu-PSMA-617 treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations