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New treatment option for Prostate Adenocarcinoma
Official title Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy
ClinicalTrials.gov ID: NCT06798558
What this study is testing
What is Lu-17-PSMA-617?
Lu-17-PSMA-617 is an investigational medicine, being studied as a potential treatment for prostate adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Male adults with a confirmed diagnosis of prostate adenocarcinoma who meet criteria for localized high risk prostate cancer according to the NCCN guidelines and who are eligible for prostatectomy will be invited to participate. Criteria for high-risk prostate cancer include patients with preoperative prostate biopsy score of Gleason 8 (GS8) (Grade group 4 [GG4]) or higher.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Patients age 18 or older.
- Patients with histologically confirmed adenocarcinoma of the prostate.
- Patients with high-risk disease defined as a preoperative prostate biopsy of Gleason Score 8 (GS8) (Grade group 4 [GG4]) or higher. Men with evidence...
- Pre-operative, pre-treatment PSMA scan with high expression in prostate confirmed by PET/CT 68Ga-PSMA-11 (greater than liver). Patients must not have...
- Patients who are able and willing to undergo surgery.
You likely can't join if
- Patients with a prior history of prostate cancer treatment.
- Patients with previous treatment with PSMA-targeted radioligand therapy or any of the following within 6 months of enrollment confirmation...
- Patients with distant disease (outside of local lymph nodes).
- Significant bone marrow impairment defined by leukocytes \<3,000/mcL, absolute neutrophil count (ANC) \<1,500/mcL, and platelet count lower than...
- Significant liver function impairment defined by total bilirubin higher than 1.5 times the upper limit of normal (ULN), andASL/ALT higher than 3...
- Impaired kidney function defined by glomerular filtration rate (GFR) lower than 40 mL/min, or concomitant use of nephrotoxic drugs. Kidney function...
See the full eligibility criteria
- Patients age 18 or older.
- Patients with histologically confirmed adenocarcinoma of the prostate.
- Patients with high-risk disease defined as a preoperative prostate biopsy of Gleason Score 8 (GS8) (Grade group 4 [GG4]) or higher. Men with evidence of lymph node involvement at or below the bifurcation of the common...
- Pre-operative, pre-treatment PSMA scan with high expression in prostate confirmed by PET/CT 68Ga-PSMA-11 (greater than liver). Patients must not have any other PET FDG-positive sites outside the prostate.
- Patients who are able and willing to undergo surgery.
- Patients with a life expectancy of greater than 10 years. Life expectancy can be estimated using any 1 of the following tools:
- The Social Security Administration tables: https://www.ssa.gov/OACT/STATS/table4c6.html
- The WHO's Life Tables by country: https://apps.who.int/gho/data/view.main.60000?lang=en
- The Memorial Sloan Kettering Male Life Expectancy tool: https://www.mskcc.org/nomograms/prostate
- If using a life expectancy table, life expectancy should be adjusted using the clinician's assessment of overall health as follows: best quartile of health - add 50%; worst quartile of health - subtract 50%; and middle...
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Patients who agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm, as defined below:
- With a female partner of childbearing potential who is not pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure...
- With a pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 14 weeks after the final dose of study treatment to avoid potential exposure to the embryo.
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation...
- Patients who are able to comply with follow-up visits and treatment plans.
- Patients who are able to give informed consent.
- Patients with a prior history of prostate cancer treatment.
- Patients with previous treatment with PSMA-targeted radioligand therapy or any of the following within 6 months of enrollment confirmation: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body...
- Patients with distant disease (outside of local lymph nodes).
- Significant bone marrow impairment defined by leukocytes \<3,000/mcL, absolute neutrophil count (ANC) \<1,500/mcL, and platelet count lower than 70,000/mcL.
- Significant liver function impairment defined by total bilirubin higher than 1.5 times the upper limit of normal (ULN), andASL/ALT higher than 3 times the ULN.
- Impaired kidney function defined by glomerular filtration rate (GFR) lower than 40 mL/min, or concomitant use of nephrotoxic drugs. Kidney function based on eGFR by Modification of Diet in Renal Disease (MDRD) equation:
- Normal renal function: participants with eGFR 90 mL/min
- Moderate renal impairment: participants with eGFR 30 to 59 mL/min
- Severe renal impairment: participants with eGFR 15 to 29 mL/min
- Patients with significant comorbidities that would make them poor candidates for surgery.
- Patients with evidence of metastatic disease (enlarged lymph nodes, distant metastatic sites, visceral or bone metastases, etc.).
- Patients with a history of radiation or hormone therapy to the prostate.
- Patients with a history of bleeding disorders or who are taking anticoagulant therapy.
- Patients with active infections or other contraindications for surgery.
- Patients who are unable or unwilling to give informed consent.
- Patients who are unable to comply with follow-up visits and treatment plans
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Hackensack, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Hackensack, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.