A Study of Stereotactic Body Radiotherapy and 177Lu-PSMA-617 for the Treatment of Prostate Cancer (NCT05079698) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of Stereotactic Body Radiotherapy and 177Lu-PSMA-617 for the Treatment of Prostate Cancer
United States29 participantsStarted 2021-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
°If patient is post-prostatectomy, the MRI Prostate can be excluded at clinician's discretion
* 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 ol…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of subjects with dose limiting toxicity (DLT) of fractionated dose of 177Lu-PSMA-617 (Pilot)