RECRUITING

A Study of Stereotactic Body Radiotherapy and 177Lu-PSMA-617 for the Treatment of Prostate Cancer

Conditions

Prostate Cancer Stereotactic Body Radiotherapy 177Lu-PSMA-617 21-158

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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 researchers are doing this study to find out whether giving 177Lu-PSMA-617 followed by a type of radiation therapy called SBRT (stereotactic body radiation therapy) is a safe treatment for your cancer. The study agent has been shown to target tumor cells, and the researchers think that adding 177Lu-PSMA-617 to SBRT may prevent or delay the cancer from continuing to spread.

Official Title

A Safety Study of Stereotactic Body Radiotherapy (SBRT) and 177Lu-PSMA617 for the Treatment of Hormone Sensitive, Oligometastatic Prostate Cancer

Quick Facts

Study Start:2021-10-01

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05079698

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
* The patient must have a biopsy proven adenocarcinoma of the prostate (biopsy confirmation of the primary tumor or oligometastatic tumor is acceptable) * The patient's primary tumor must have been previously treated with surgery and/or definitive radiation. Prior salvage treatments (radiation or surgery) to the prostate bed or pelvis is allowed. * Patients must have a negative multiparametric MRI and/or negative biopsy of the prostate (or prostate bed) even if other imaging modality (including PSMA) was negative for disease in the prostate (or prostate bed) within 2 months of enrollment on study * Patients must have had a PSMA scan within 2 months of enrollment on study * Patient has not received any form of prostate-cancer directed therapy since undergoing screening PSMA scan * Patient must have 1-5 oligometastatic tumors or lesions of the bone or soft tissue that are detectable on a PSMA PET scan. * Outside PSMA scans not performed at MSKCC are acceptable but will require official read by MSKCC nuclear medicine for confirmation of metastasis * Patients with sclerotic, non-PSMA avid osseous lesions which are not felt to reflect active metastatic disease by a radiologist are eligible for the protocol assuming they also have 1-5sites of PSMA avid disease as well as no non-PSMA avid sites which are felt to reflect active metastatic prostate cancer * All oligometastatic lesions must be amenable to SBRT to a dose of 9 Gy x 3 without exceeding nationally recognized dose limits to adjacent organs at risk as deemed by the treating radiation oncologist * Patient's insurance is willing to cover SBRT treatment or the patient agrees to cover the costs of this therapy * Patient must have a prostate specific antigen (PSA) ≥ 0.2 ng/mL but ≤ 50 ng/mL * Patient may have had prior systemic therapy and/or ADT associated with treatment of their primary prostate cancer. Patient may have had ADT associated with salvage radiation therapy. * Patients who have been on hormone therapy within 12 months of consent must have testosterone within normal range (221-716 ng/dL at MSKCC) in order to be eligible for treatment on study. * Baseline testosterone below the normal range for patients who have not had hormone therapy within 12 months of study entry is acceptable * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Patient must have a serum creatinine level \< 1.5 x ULN or EGFR \> 60 mL/min * Patient must have adequate liver laboratory values: * ALT and AST ≤ 2.5 x ULN * Albumin \> 2 g/ dL * Bilirubin \< 3 X ULN * Patient must have normal organ and marrow function as defined as: * Total white blood count \> 3.0 K/mcL * Absolute Neutrophil Count ≥ 1.5 K/mcL * Platelets ≥ 100 K/mcL * Hemoglobin ≥ 9 g/dL * The effects of 177Lu-PSMA-617 and SBRT on the developing human fetus at the recommended therapeutic dose are unknown. Men (including men with vasectomies) must agree to use adequate contraception (a condom and another effective method of birth control) prior to registration, for the duration of study participation, and for at least 3 months thereafter. Men must also agree not to donate sperm for the duration of study participation, and for at least 3 months thereafter. * Patient must be ≥ 18 years of age * Ability to understand, and willingness to sign the informed consent	* Pathological findings consistent with small cell and/or neuroendocrine carcinoma of the prostate or any other histology not consistent with prostate adenocarcinoma * Patients with documented castration resistant prostate cancer (CRPC) * Patients with a PSMA scan within 2 months of enrollment that do not demonstrate metastatic lesions or demonstrate more than 5 discrete metastatic lesions * Patients with PSMA negative metastatic lesions or with a mixture of PSMA avid and PSMA negative disease * Patients with metastatic lesions not amenable to SBRT or treatment of which using a 9 Gy x 3 regimen would result in exceeding nationally accepted or institutional dose limits for nearby organs at risk * Patients with previous radiation therapy for oligometastatic disease are still eligible * Patients with prior radiotherapy to \> 25% of the skeleton or prior exposure to prior 223Radium, 89Strontium or 153Samarium containing compounds * Patients with spinal cord compression, impending spinal cord compression, or parenchymal brain metastases (patients with epidural disease without cord compression are eligible) * History of another malignancy within the previous 3 years except for the following: adequately treated basal cell or squamous cell skin cancer * Patients with known or suspected history of grade II or higher chronic kidney disease (CKD) * Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to registration. * Seizure or known condition that may predispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to enrollment, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect) * Gastrointestinal disorder affecting absorption * History of viral hepatitis or chronic liver disease with active symptoms * History of pituitary or adrenal dysfunction * Previously diagnosed active infection (e.g., human immunodeficiency virus \[HIV\] or viral hepatitis) * Any condition that in the opinion of the investigator, would preclude participation in this study * Concurrent corticosteroids and/or adrenal hormone inhibitors, PC-SPES, finasteride, or dutasteride is not allowed. * Receipt of any other investigational agents or participation in a concurrent treatment protocol * Inability to life flat during or tolerate PET CT/MR or SBRT * Patients must not have claustrophobia that would preclude PET/CT imaging or other contraindications to CT imaging * Known allergies, hypersensitivities, or intolerance to Lu-PSMA-617 or its inactive compounding components

Inclusion Criteria

Exclusion Criteria

* The patient must have a biopsy proven adenocarcinoma of the prostate (biopsy confirmation of the primary tumor or oligometastatic tumor is acceptable)
* The patient's primary tumor must have been previously treated with surgery and/or definitive radiation. Prior salvage treatments (radiation or surgery) to the prostate bed or pelvis is allowed.
* Patients must have a negative multiparametric MRI and/or negative biopsy of the prostate (or prostate bed) even if other imaging modality (including PSMA) was negative for disease in the prostate (or prostate bed) within 2 months of enrollment on study
* Patients must have had a PSMA scan within 2 months of enrollment on study
* Patient has not received any form of prostate-cancer directed therapy since undergoing screening PSMA scan
* Patient must have 1-5 oligometastatic tumors or lesions of the bone or soft tissue that are detectable on a PSMA PET scan.
* Outside PSMA scans not performed at MSKCC are acceptable but will require official read by MSKCC nuclear medicine for confirmation of metastasis
* Patients with sclerotic, non-PSMA avid osseous lesions which are not felt to reflect active metastatic disease by a radiologist are eligible for the protocol assuming they also have 1-5sites of PSMA avid disease as well as no non-PSMA avid sites which are felt to reflect active metastatic prostate cancer
* All oligometastatic lesions must be amenable to SBRT to a dose of 9 Gy x 3 without exceeding nationally recognized dose limits to adjacent organs at risk as deemed by the treating radiation oncologist
* Patient's insurance is willing to cover SBRT treatment or the patient agrees to cover the costs of this therapy
* Patient must have a prostate specific antigen (PSA) ≥ 0.2 ng/mL but ≤ 50 ng/mL
* Patient may have had prior systemic therapy and/or ADT associated with treatment of their primary prostate cancer. Patient may have had ADT associated with salvage radiation therapy.
* Patients who have been on hormone therapy within 12 months of consent must have testosterone within normal range (221-716 ng/dL at MSKCC) in order to be eligible for treatment on study.
* Baseline testosterone below the normal range for patients who have not had hormone therapy within 12 months of study entry is acceptable
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Patient must have a serum creatinine level \< 1.5 x ULN or EGFR \> 60 mL/min
* Patient must have adequate liver laboratory values:
* ALT and AST ≤ 2.5 x ULN
* Albumin \> 2 g/ dL
* Bilirubin \< 3 X ULN
* Patient must have normal organ and marrow function as defined as:
* Total white blood count \> 3.0 K/mcL
* Absolute Neutrophil Count ≥ 1.5 K/mcL
* Platelets ≥ 100 K/mcL
* Hemoglobin ≥ 9 g/dL
* The effects of 177Lu-PSMA-617 and SBRT on the developing human fetus at the recommended therapeutic dose are unknown. Men (including men with vasectomies) must agree to use adequate contraception (a condom and another effective method of birth control) prior to registration, for the duration of study participation, and for at least 3 months thereafter. Men must also agree not to donate sperm for the duration of study participation, and for at least 3 months thereafter.
* Patient must be ≥ 18 years of age
* Ability to understand, and willingness to sign the informed consent

* Pathological findings consistent with small cell and/or neuroendocrine carcinoma of the prostate or any other histology not consistent with prostate adenocarcinoma
* Patients with documented castration resistant prostate cancer (CRPC)
* Patients with a PSMA scan within 2 months of enrollment that do not demonstrate metastatic lesions or demonstrate more than 5 discrete metastatic lesions
* Patients with PSMA negative metastatic lesions or with a mixture of PSMA avid and PSMA negative disease
* Patients with metastatic lesions not amenable to SBRT or treatment of which using a 9 Gy x 3 regimen would result in exceeding nationally accepted or institutional dose limits for nearby organs at risk
* Patients with previous radiation therapy for oligometastatic disease are still eligible
* Patients with prior radiotherapy to \> 25% of the skeleton or prior exposure to prior 223Radium, 89Strontium or 153Samarium containing compounds
* Patients with spinal cord compression, impending spinal cord compression, or parenchymal brain metastases (patients with epidural disease without cord compression are eligible)
* History of another malignancy within the previous 3 years except for the following: adequately treated basal cell or squamous cell skin cancer
* Patients with known or suspected history of grade II or higher chronic kidney disease (CKD)
* Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to registration.
* Seizure or known condition that may predispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to enrollment, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
* Gastrointestinal disorder affecting absorption
* History of viral hepatitis or chronic liver disease with active symptoms
* History of pituitary or adrenal dysfunction
* Previously diagnosed active infection (e.g., human immunodeficiency virus \[HIV\] or viral hepatitis)
* Any condition that in the opinion of the investigator, would preclude participation in this study
* Concurrent corticosteroids and/or adrenal hormone inhibitors, PC-SPES, finasteride, or dutasteride is not allowed.
* Receipt of any other investigational agents or participation in a concurrent treatment protocol
* Inability to life flat during or tolerate PET CT/MR or SBRT
* Patients must not have claustrophobia that would preclude PET/CT imaging or other contraindications to CT imaging
* Known allergies, hypersensitivities, or intolerance to Lu-PSMA-617 or its inactive compounding components

Contacts and Locations

Study Contact

Brandon Imber, MD

CONTACT

631-212-6346

imberb@mskcc.org

Michael Morris, MD

CONTACT

646-422-4469

Principal Investigator

Brandon Imber, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Brandon Imber, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

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 Date2021-10-01

Study Completion Date2025-10

Study Record Updates

Study Start Date2021-10-01

Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

Stereotactic Body Radiotherapy
177Lu-PSMA-617
21-158

Additional Relevant MeSH Terms

Prostate Cancer