RECRUITING

PSMAtrack-tracking Changes in PSMA-PET During Initial Therapy for Metastatic Hormone-sensitive Prostate Cancer

Conditions

Metastatic Prostate Cancer Hormone Sensitive Prostate Cancer Metastatic Hormone-sensitive Prostate Cancer (mHSPC)PSMA PET prostate cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn if serial PSMA-PET/CT scans can be used to monitor response to therapy in metastatic hormone sensitive prostate cancer and can be potentially used to optimize future treatment approaches. The main questions it aims to answer are: What is the proportion of men with residual PSMA-avid disease on PET/CT scans after 6 months of treatment for metastatic hormone sensitive prostate cancer? Do the findings on PSMA-PET/CT scans after 6 months of treatment for metastatic hormone sensitive prostate cancer correlate with other markers of disease status, like PSA? Participants will: Receive standard of care treatment for metastatic hormone sensitive prostate cancer Undergo a PSMA-PET/CT scan before starting treatment Undergo a PSMA-PET/CT scan after 6 months of treatment Have a chart review every 3 months for 1 year after the 6 month PSMA-PET/CT scan

Official Title

PSMAtrack-tracking Changes in PSMA-PET During Initial Therapy for Metastatic Hormone-sensitive Prostate Cancer

Quick Facts

Study Start:2024-06-30

Study Completion:2027-06-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06479187

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Participants must have histologically or cytologically confirmed prostate cancer, or unequivocal clinical evidence of mHSPC (eg. elevated PSA with lesions consistent with metastatic prostate cancer). 2. Age ≥18 years. 3. Participants must have mHSPC (either de novo or relapse after prior local therapy), as defined by extrapelvic nodal and/or visceral and/or bone lesions consistent with metastatic disease and seen on CT, bone scan and/or MRI. If participants have relapsed after prior local therapy, they must not have had systemic therapy in the past 6 months prior to study registration. 4. Serum testosterone \>150 ng/dL. 5. Planned initiation of systemic therapy with ADT (androgen deprivation therapy) and an AR pathway inhibitor (abiraterone, enzalutamide, apalutamide, darolutamide) ± docetaxel. Initiation of systemic therapy up to 14 days prior to the baseline 18F-rhPSMA-7.3 PSMA-PET/CT is permitted. 6. Ability and willingness to comply with the study procedures. 7. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational agent are eligible for this trial. 8. The effects of 18F-rhPSMA-7.3 on the developing human fetus are unknown. For this reason and because radiopharmaceutical agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 24 hours after each 18F-rhPSMA-7.3 PSMA-PET scan. 9. Ability to understand and the willingness to sign a written informed consent document.	1. Systemic therapies other than ADT (GnRH/LHRH agonists or antagonists), AR pathways inhibitors (abiraterone, enzalutamide, apalutamide, darolutamide) and docetaxel are not permitted to be administered during the study period. 2. Radiation to the prostate and/or metastatic sites prior to the 6-month PET scan is not permitted. 3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 4. Contraindications to PET/CT, including severe claustrophobia. 5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-rhPSMA-7.3. 6. Any past or current condition that, in the opinion of the study investigators, would confound the results of the study or would pose additional risk or burden to the patient by their participation in the study.

Inclusion Criteria

Exclusion Criteria

1. Participants must have histologically or cytologically confirmed prostate cancer, or unequivocal clinical evidence of mHSPC (eg. elevated PSA with lesions consistent with metastatic prostate cancer).
2. Age ≥18 years.
3. Participants must have mHSPC (either de novo or relapse after prior local therapy), as defined by extrapelvic nodal and/or visceral and/or bone lesions consistent with metastatic disease and seen on CT, bone scan and/or MRI. If participants have relapsed after prior local therapy, they must not have had systemic therapy in the past 6 months prior to study registration.
4. Serum testosterone \>150 ng/dL.
5. Planned initiation of systemic therapy with ADT (androgen deprivation therapy) and an AR pathway inhibitor (abiraterone, enzalutamide, apalutamide, darolutamide) ± docetaxel. Initiation of systemic therapy up to 14 days prior to the baseline 18F-rhPSMA-7.3 PSMA-PET/CT is permitted.
6. Ability and willingness to comply with the study procedures.
7. Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational agent are eligible for this trial.
8. The effects of 18F-rhPSMA-7.3 on the developing human fetus are unknown. For this reason and because radiopharmaceutical agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 24 hours after each 18F-rhPSMA-7.3 PSMA-PET scan.
9. Ability to understand and the willingness to sign a written informed consent document.

1. Systemic therapies other than ADT (GnRH/LHRH agonists or antagonists), AR pathways inhibitors (abiraterone, enzalutamide, apalutamide, darolutamide) and docetaxel are not permitted to be administered during the study period.
2. Radiation to the prostate and/or metastatic sites prior to the 6-month PET scan is not permitted.
3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
4. Contraindications to PET/CT, including severe claustrophobia.
5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-rhPSMA-7.3.
6. Any past or current condition that, in the opinion of the study investigators, would confound the results of the study or would pose additional risk or burden to the patient by their participation in the study.

Contacts and Locations

Study Contact

Heather A Jacene, MD

CONTACT

617-632-3767

hjacene@bwh.harvard.edu

Principal Investigator

Heather Jacene, MD

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Heather Jacene, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-30

Study Completion Date2027-06-20

Study Record Updates

Study Start Date2024-06-30

Study Completion Date2027-06-20

Terms related to this study

Keywords Provided by Researchers

PSMA
PET
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
prostate cancer

Additional Relevant MeSH Terms

Metastatic Prostate Cancer
Hormone Sensitive Prostate Cancer
Metastatic Hormone-sensitive Prostate Cancer (mHSPC)