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

Who is this study for? Patients with Prostate Cancer
What treatments are being studied? 177Lu-PSMA-617+Stereotactic Body Radiotherapy (SBRT)
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Commack (Limited Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
RECRUITING
Uniondale
Contact Information
Primary
Brandon Imber, MD
imberb@mskcc.org
631-212-6346
Backup
Michael Morris, MD
646-422-4469
Time Frame
Start Date: 2021-10-01
Estimated Completion Date: 2025-10
Participants
Target number of participants: 27
Treatments
Experimental: Stereotactic Body Radiotherapy and 177Lu-PSMA-617
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center
Collaborators: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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