Prostate AdenocarcinomaPhase 2NCT06798558

Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy

A Phase 2 study testing Lu-17-PSMA-617 in people with Prostate Adenocarcinoma, run by Hackensack Meridian Health at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Adenocarcinoma
What is being tested?: Lu-17-PSMA-617
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 3 sitesUnited States
Study dates: 5 Mar 2025to Mar 2029
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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 iliac arteries (cN1) on PET-CT 68Ga-PSMA-11 are eligible.
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:

Show all 20Show fewer

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 two quartiles of health - no adjustment. See the NCCN Prostate Cancer Guidelines for more information.
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 rate of \&amp;lt; 1% per year during the treatment period and for 14 weeks after the final dose of study treatment. Men must refrain from donating sperm during this same period.
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, symptothermal, or post-ovulation methods) and withdrawal are not adequate methods of contraception.
Patients who are able to comply with follow-up visits and treatment plans.
Patients who are able to give informed consent.

Who cannot join

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 irradiation.
Patients with distant disease (outside of local lymph nodes).
Significant bone marrow impairment defined by leukocytes \&amp;lt;3,000/mcL, absolute neutrophil count (ANC) \&amp;lt;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:

Show all 16Show fewer

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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Oncology Clinical Research Referral Office contact

551-996-1777

OncologyResearchReferral@hmhn.org

United States3 sites, 3 recruiting

John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Nitin Yerram, MD
Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Ross Krasnow, MD
Not yet recruiting
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, 20057
Paul Leger, MD
Not yet recruiting

Other trials in United States

About this study

Official title: Phase II Study of Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy

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. Patients also need to have a positive PSMA scan on 68-Ga-PSMA-11 PET/CT scan.

Read the detailed description

The PRELUDE trial is a prospective, non-randomized, single-arm, phase 2 interventional study to assess the oncological outcomes after 2 cycles of Lu-177-PSMA-617 (PluvictoⓇ) administered at 6-week intervals before prostatectomy in patients with high risk localized prostate cancer.

Patients who meet all the inclusion criteria for the study will be enrolled to receive 2 cycles of Lu-177-PSMA-617 (PluvictoⓇ) administered at the dose of 7.4 GBq (±10%), once every 6 weeks (±1 week). Six weeks after the second cycle of Lu-177-PSMA-617 (PluvictoⓇ), patients will be eligible for radical prostatectomy with pelvic lymph node dissection and remain eligible for surgery up until 30 days from this timepoint.

Following treatment with Lu-177-PSMA-617 (PluvictoⓇ) and surgery, all participants will be followed for safety at week 3, 6, 9, 11, and 12 as well as a 30-day safety follow-up visit (FUP) and longer term safety follow-up assessments every 3 months for a period of approximately 2 years. Patients who experience disease progression will be managed according to standard treatment guidelines recommendations.

Conditions: Prostate Adenocarcinoma
Being tested: Lu-17-PSMA-617

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lu-17-PSMA-617Drug
Lu-17-PSMA-617 administration

Study groups in NCT06798558
Study group	Role	What they receive
Lu-177-PSMA-617 Treatment	Experimental	Patients will receive 2 cycles of Lu-177-PSMA-617 (PluvictoⓇ) administered at the dose of 7.4 GBq (±10%), once every 6 weeks (±1 week) Receives: Drug: Lu-17-PSMA-617

What is being measured

The primary outcome is the main question the study is designed to answer.

Prostate cancer down-staging following treatment with Lu-177-PSMA-617 (PluvictoⓇ) defined by Gleason Grade Group
Staging of prostate cancer is based on the correlation to Gleason Grade Group (GG) according to the American Joint Committee on Cancer (AJCC; 8TH edition, 2017) staging system for prostate cancer (see Appendix A). Prostate cancer downstaging is defined as the post-treatment stage less than the pre-treatment stage. Different downstaging thresholds will be applied including:
- Complete downstaging (CD) is defined as no visible tumor in surgical sample;
- Good response (GR) is defined as downstaging from high risk disease (GG4 or greater) to intermediate risk pathologic disease (GG2 or GG3 disease); and
- Very good response (VGR) is defined as downstaging from high-risk disease (GG4 or greater) to low risk pathologic disease (GG1 disease).
Measured: Patients will undergo a PSMA PET/CT scans up to week 11 +/- 30 days prior to radical prostatectomy with pelvic lymph node dissection.

Secondary outcomes (9)

Prostate cancer down-staging following treatment with Lu-177-PSMA-617 (PluvictoⓇ) as defined by margin status, T staging, and seminal vesicle involvement
Staging of prostate cancer is based on the American Joint Committee on Cancer (AJCC; 8TH edition, 2017) combining the TNM staging system for prostate cancer with the Gleason Grade Group (GG)
Measured: Patients will undergo a PSMA PET/CT scans up to week 11 +/- 30 days prior to radical prostatectomy with pelvic lymph node dissection.
Decrease in PSMA-avid tumor load
Decrease in PSMA-avid tumor load is measured by comparing the extent of PSMA-avid tumor before and after Lu-177-PSMA-617 (PluvictoⓇ). High PSMA-avidity is defined as more than 2 times the liver activity. Low PSMA-avidity is defined as less than 2 times liver activity. The volumes of PSMA-avid disease will be summed up to quantify the extent of PSMA-avid tumor load before and after Lu-177-PSMA-617 (PluvictoⓇ). PSMA-positive disease is measured using 68Ga-PSMA-11 PET/CT scan.
Measured: Patients will undergo a SOC PSMA PET/CT scans up to week 11 +/- 30 days prior to radical prostatectomy with pelvic lymph node dissection.
Safety of radical prostatectomy assessed by surgical delay time
The safety of radical prostatectomy and pelvic lymph node dissection following Lu-177-PSMA-617 (PluvictoⓇ) is defined as the surgical delay time. Surgical delay time is defined as days between the last dose of Lu-177-PSMA-617 (PluvictoⓇ) and the date of radical prostatectomy. All surgeries will be assessed by each surgeon at the end of the procedure and graded as similar to, more difficult than, or significantly more difficult than expected for a high-risk radical prostatectomy (Eapen 2023). Adverse events (AEs) of Lu-177-PSMA-617 (PluvictoⓇ) and surgery will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 or severity grade when CTCAE grading does not exist.
Measured: Patients will be assessed for toxicity throughout treatment with Lu-177-PSMA-617 (PluvictoⓇ) and during surgery. Following treatment with Lu-177-PSMA-617 (PluvictoⓇ) and surgery, all participants will be followed for safety with a 30-day safety follow-up
Safety of radical prostatectomy assessed by rate of intraoperative and postoperative complications
The safety of radical prostatectomy and pelvic lymph node dissection following Lu-177-PSMA-617 (PluvictoⓇ) is defined as the rate of intraoperative and postoperative complications. All surgeries will be assessed by each surgeon at the end of the procedure and graded as similar to, more difficult than, or significantly more difficult than expected for a high-risk radical prostatectomy (Eapen 2023). Adverse events (AEs) of Lu-177-PSMA-617 (PluvictoⓇ) and surgery will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 or severity grade when CTCAE grading does not exist.
Measured: Patients will be assessed for toxicity throughout treatment with Lu-177-PSMA-617 (PluvictoⓇ) and during surgery. Following treatment with Lu-177-PSMA-617 (PluvictoⓇ) and surgery, all participants will be followed for safety with a 30-day safety follow-up
Safety of radical prostatectomy assessed by the amount of blood loss
The safety of radical prostatectomy and pelvic lymph node dissection following Lu-177-PSMA-617 (PluvictoⓇ) is defined as the amount of blood loss. All surgeries will be assessed by each surgeon at the end of the procedure and graded as similar to, more difficult than, or significantly more difficult than expected for a high-risk radical prostatectomy (Eapen 2023). Adverse events (AEs) of Lu-177-PSMA-617 (PluvictoⓇ) and surgery will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 or severity grade when CTCAE grading does not exist.
Measured: Patients will be assessed for toxicity throughout treatment with Lu-177-PSMA-617 (PluvictoⓇ) and during surgery. Following treatment with Lu-177-PSMA-617 (PluvictoⓇ) and surgery, all participants will be followed for safety with a 30-day safety follow-up
Safety of radical prostatectomy assessed by percentage of periprostatic adhesion
The safety of radical prostatectomy and pelvic lymph node dissection following Lu-177-PSMA-617 (PluvictoⓇ) is defined as the percentage of periprostatic adhesion. All surgeries will be assessed by each surgeon at the end of the procedure and graded as similar to, more difficult than, or significantly more difficult than expected for a high-risk radical prostatectomy (Eapen 2023). Adverse events (AEs) of Lu-177-PSMA-617 (PluvictoⓇ) and surgery will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 or severity grade when CTCAE grading does not exist.
Measured: Patients will be assessed for toxicity throughout treatment with Lu-177-PSMA-617 (PluvictoⓇ) and during surgery. Following treatment with Lu-177-PSMA-617 (PluvictoⓇ) and surgery, all participants will be followed for safety with a 30-day safety follow-up
Safety of radical prostatectomy assessed by the surgical length of time
The safety of radical prostatectomy and pelvic lymph node dissection following Lu-177-PSMA-617 (PluvictoⓇ) is defined as the surgical length of time. All surgeries will be assessed by each surgeon at the end of the procedure and graded as similar to, more difficult than, or significantly more difficult than expected for a high-risk radical prostatectomy (Eapen 2023). Adverse events (AEs) of Lu-177-PSMA-617 (PluvictoⓇ) and surgery will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 or severity grade when CTCAE grading does not exist.
Measured: Patients will be assessed for toxicity throughout treatment with Lu-177-PSMA-617 (PluvictoⓇ) and during surgery. Following treatment with Lu-177-PSMA-617 (PluvictoⓇ) and surgery, all participants will be followed for safety with a 30-day safety follow-up
Quality-of-life and sexual function changes
Quality-of-life and sexual function changes following treatment with Lu-177-PSMA-617 (PluvictoⓇ) and prostatectomy will be measured using the Expanded Prostate Index Composite (EPIC)-26 questionnaire.
Measured: The EPIC-26 questionnaire will be completed by patients up to 24 months after prostatectomy
Biochemical recurrence of prostate cancer at 2 years
Biochemical recurrence is defined as a serum prostate-specific antigen (PSA) level more than 0.2 ng/mL on 2 consecutive measurements performed at least 3 months apart.
Timeframe: PSA levels will be measured at screening/baseline, at the initiation of treatment
Measured: PSA levels will be measured up to 24 months after prostatectomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Mar 2025Mar 2029

First posted29 Jan 2025
Study start5 Mar 2025
Primary completionMar 2029 (estimated)
Study completionMar 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (44)Papers the sponsor has linked to this study.
Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 54 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06798558
Sponsor's protocol ID: Pro2024-0079
Other IDs: CAAA617A1US07T, PRELUDE
Status last verified: Mar 2026
First submitted: 17 Jan 2025
Last updated: 23 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Aalberts M, Stout TA, Stoorvogel W. Prostasomes: extracellular vesicles from the prostate. Reproduction. 2013 Nov 16;147(1):R1-14. doi: 10.1530/REP-13-0358. Print 2014 Jan.
PubMed 24149515
Powell IJ, Dyson G, Land S, Ruterbusch J, Bock CH, Lenk S, Herawi M, Everson R, Giroux CN, Schwartz AG, Bollig-Fischer A. Genes associated with prostate cancer are differentially expressed in African American and European American men. Cancer Epidemiol Biomarkers Prev. 2013 May;22(5):891-7. doi: 10.1158/1055-9965.EPI-12-1238. Epub 2013 Mar 20.
PubMed 23515145
Attard G, Murphy L, Clarke NW, Cross W, Jones RJ, Parker CC, Gillessen S, Cook A, Brawley C, Amos CL, Atako N, Pugh C, Buckner M, Chowdhury S, Malik Z, Russell JM, Gilson C, Rush H, Bowen J, Lydon A, Pedley I, O'Sullivan JM, Birtle A, Gale J, Srihari N, Thomas C, Tanguay J, Wagstaff J, Das P, Gray E, Alzoueb M, Parikh O, Robinson A, Syndikus I, Wylie J, Zarkar A, Thalmann G, de Bono JS, Dearnaley DP, Mason MD, Gilbert D, Langley RE, Millman R, Matheson D, Sydes MR, Brown LC, Parmar MKB, James ND; Systemic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) investigators. Abiraterone acetate and prednisolone with or without enzalutamide for high-risk non-metastatic prostate cancer: a meta-analysis of primary results from two randomised controlled phase 3 trials of the STAMPEDE platform protocol. Lancet. 2022 Jan 29;399(10323):447-460. doi: 10.1016/S0140-6736(21)02437-5. Epub 2021 Dec 23.
PubMed 34953525
Bebelman MP, Janssen E, Pegtel DM, Crudden C. The forces driving cancer extracellular vesicle secretion. Neoplasia. 2021 Jan;23(1):149-157. doi: 10.1016/j.neo.2020.11.011. Epub 2020 Dec 14.
PubMed 33321449
Becker A, Thakur BK, Weiss JM, Kim HS, Peinado H, Lyden D. Extracellular Vesicles in Cancer: Cell-to-Cell Mediators of Metastasis. Cancer Cell. 2016 Dec 12;30(6):836-848. doi: 10.1016/j.ccell.2016.10.009.
PubMed 27960084
Carlsson L, Pahlson C, Bergquist M, Ronquist G, Stridsberg M. Antibacterial activity of human prostasomes. Prostate. 2000 Sep 1;44(4):279-86. doi: 10.1002/1097-0045(20000901)44:43.0.co;2-2.
PubMed 10951492
Cooperberg MR, Cowan J, Broering JM, Carroll PR. High-risk prostate cancer in the United States, 1990-2007. World J Urol. 2008 Jun;26(3):211-8. doi: 10.1007/s00345-008-0250-7. Epub 2008 Mar 28.
PubMed 18369637
D'Amico AV, Whittington R, Malkowicz SB, Fondurulia J, Chen MH, Kaplan I, Beard CJ, Tomaszewski JE, Renshaw AA, Wein A, Coleman CN. Pretreatment nomogram for prostate-specific antigen recurrence after radical prostatectomy or external-beam radiation therapy for clinically localized prostate cancer. J Clin Oncol. 1999 Jan;17(1):168-72. doi: 10.1200/JCO.1999.17.1.168.
PubMed 10458230
D'Amico AV, Whittington R, Malkowicz SB, Fondurulia J, Chen MH, Tomaszewski JE, Wein A. The combination of preoperative prostate specific antigen and postoperative pathological findings to predict prostate specific antigen outcome in clinically localized prostate cancer. J Urol. 1998 Dec;160(6 Pt 1):2096-101. doi: 10.1097/00005392-199812010-00041.
PubMed 9817331
D'Amico AV, Whittington R, Malkowicz SB, Schultz D, Blank K, Broderick GA, Tomaszewski JE, Renshaw AA, Kaplan I, Beard CJ, Wein A. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA. 1998 Sep 16;280(11):969-74. doi: 10.1001/jama.280.11.969.
PubMed 9749478
Eapen RS, Buteau JP, Jackson P, Mitchell C, Oon SF, Alghazo O, McIntosh L, Dhiantravan N, Scalzo MJ, O'Brien J, Sandhu S, Azad AA, Williams SG, Sharma G, Haskali MB, Bressel M, Chen K, Jenjitranant P, McVey A, Moon D, Lawrentschuk N, Neeson PJ, Murphy DG, Hofman MS. Administering [177Lu]Lu-PSMA-617 Prior to Radical Prostatectomy in Men with High-risk Localised Prostate Cancer (LuTectomy): A Single-centre, Single-arm, Phase 1/2 Study. Eur Urol. 2024 Mar;85(3):217-226. doi: 10.1016/j.eururo.2023.08.026. Epub 2023 Oct 26.
PubMed 37891072
Fabiani R, Johansson L, Lundkvist O, Ronquist G. Enhanced recruitment of motile spermatozoa by prostasome inclusion in swim-up medium. Hum Reprod. 1994 Aug;9(8):1485-9. doi: 10.1093/oxfordjournals.humrep.a138735.
PubMed 7989510
Gafita A, Djaileb L, Rauscher I, Fendler WP, Hadaschik B, Rowe SP, Herrmann K, Calais J, Rettig M, Eiber M, Weber M, Benz MR, Farolfi A. Response Evaluation Criteria in PSMA PET/CT (RECIP 1.0) in Metastatic Castration-resistant Prostate Cancer. Radiology. 2023 Jul;308(1):e222148. doi: 10.1148/radiol.222148.
PubMed 37432081
Gafita A, Rauscher I, Weber M, Hadaschik B, Wang H, Armstrong WR, Tauber R, Grogan TR, Czernin J, Rettig MB, Herrmann K, Calais J, Weber WA, Benz MR, Fendler WP, Eiber M. Novel Framework for Treatment Response Evaluation Using PSMA PET/CT in Patients with Metastatic Castration-Resistant Prostate Cancer (RECIP 1.0): An International Multicenter Study. J Nucl Med. 2022 Nov;63(11):1651-1658. doi: 10.2967/jnumed.121.263072. Epub 2022 Apr 14.
PubMed 35422442
Ginini L, Billan S, Fridman E, Gil Z. Insight into Extracellular Vesicle-Cell Communication: From Cell Recognition to Intracellular Fate. Cells. 2022 Apr 19;11(9):1375. doi: 10.3390/cells11091375.
PubMed 35563681

Interested in taking part?

Oncology Clinical Research Referral Office

551-996-1777

OncologyResearchReferral@hmhn.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study of Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy
ClinicalTrials.gov ID: NCT06798558
Acronym / sponsor ID: Pro2024-0079
Conditions: Prostate Adenocarcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 54 participants (estimated)
Lead sponsor: Hackensack Meridian HealthUniversity, hospital or other
Collaborators: Lombardi Comprehensive Cancer Center, Novartis
Study start: 5 Mar 2025 (actual)
Primary completion: Mar 2029 (estimated)
Study completion: Mar 2029 (estimated)
First posted: 29 Jan 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Lu-177-PSMA-617 Treatment	Experimental	Drug: Lu-17-PSMA-617Patients will receive 2 cycles of Lu-177-PSMA-617 (PluvictoⓇ) administered at the dose of 7.4 GBq (±10%), once every 6 weeks (±1 week)

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

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 iliac arteries (cN1) on PET-CT 68Ga-PSMA-11 are eligible.
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.

Key exclusion criteria (16 listed)

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 irradiation.
Patients with distant disease (outside of local lymph nodes).
Significant bone marrow impairment defined by leukocytes \&amp;lt;3,000/mcL, absolute neutrophil count (ANC) \&amp;lt;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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lu-17-PSMA-617Lu-17-PSMA-617 administration	Drug	Lu-177-PSMA-617 Treatment

Primary outcome

Prostate cancer down-staging following treatment with Lu-177-PSMA-617 (PluvictoⓇ) defined by Gleason Grade Group
Time frame: Patients will undergo a PSMA PET/CT scans up to week 11 +/- 30 days prior to radical prostatectomy with pelvic lymph node dissection.
Staging of prostate cancer is based on the correlation to Gleason Grade Group (GG) according to the American Joint Committee on Cancer (AJCC; 8TH edition, 2017) staging system for prostate cancer (see Appendix A). Prostate cancer downstaging is defined as the post-treatment stage less than the pre-treatment stage. Different downstaging thresholds will be applied including: * Complete downstaging (CD) is defined as no visible tumor in surgical sample; * Good response (GR) is defined as downstaging from high risk disease (GG4 or greater) to intermediate risk pathologic disease (GG2 or GG3 disease); and * Very good response (VGR) is defined as downstaging from high-risk disease (GG4 or greater) to low risk pathologic disease (GG1 disease).

9 secondary outcomes

Prostate cancer down-staging following treatment with Lu-177-PSMA-617 (PluvictoⓇ) as defined by margin status, T staging, and seminal vesicle involvement
Time frame: Patients will undergo a PSMA PET/CT scans up to week 11 +/- 30 days prior to radical prostatectomy with pelvic lymph node dissection.
Decrease in PSMA-avid tumor load
Time frame: Patients will undergo a SOC PSMA PET/CT scans up to week 11 +/- 30 days prior to radical prostatectomy with pelvic lymph node dissection.
Safety of radical prostatectomy assessed by surgical delay time
Time frame: Patients will be assessed for toxicity throughout treatment with Lu-177-PSMA-617 (PluvictoⓇ) and during surgery. Following treatment with Lu-177-PSMA-617 (PluvictoⓇ) and surgery, all participants will be followed for safety with a 30-day safety follow-up
Safety of radical prostatectomy assessed by rate of intraoperative and postoperative complications
Time frame: Patients will be assessed for toxicity throughout treatment with Lu-177-PSMA-617 (PluvictoⓇ) and during surgery. Following treatment with Lu-177-PSMA-617 (PluvictoⓇ) and surgery, all participants will be followed for safety with a 30-day safety follow-up
Safety of radical prostatectomy assessed by the amount of blood loss
Time frame: Patients will be assessed for toxicity throughout treatment with Lu-177-PSMA-617 (PluvictoⓇ) and during surgery. Following treatment with Lu-177-PSMA-617 (PluvictoⓇ) and surgery, all participants will be followed for safety with a 30-day safety follow-up
Safety of radical prostatectomy assessed by percentage of periprostatic adhesion
Time frame: Patients will be assessed for toxicity throughout treatment with Lu-177-PSMA-617 (PluvictoⓇ) and during surgery. Following treatment with Lu-177-PSMA-617 (PluvictoⓇ) and surgery, all participants will be followed for safety with a 30-day safety follow-up
Safety of radical prostatectomy assessed by the surgical length of time
Time frame: Patients will be assessed for toxicity throughout treatment with Lu-177-PSMA-617 (PluvictoⓇ) and during surgery. Following treatment with Lu-177-PSMA-617 (PluvictoⓇ) and surgery, all participants will be followed for safety with a 30-day safety follow-up
Quality-of-life and sexual function changes
Time frame: The EPIC-26 questionnaire will be completed by patients up to 24 months after prostatectomy
Biochemical recurrence of prostate cancer at 2 years
Time frame: PSA levels will be measured up to 24 months after prostatectomy

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
Background: PubMed 24149515Aalberts M, Stout TA, Stoorvogel W. Prostasomes: extracellular vesicles from the prostate. Reproduction. 2013 Nov 16;147(1):R1-14. doi: 10.1530/REP-13-0358. Print 2014 Jan.
Background: PubMed 23515145Powell IJ, Dyson G, Land S, Ruterbusch J, Bock CH, Lenk S, Herawi M, Everson R, Giroux CN, Schwartz AG, Bollig-Fischer A. Genes associated with prostate cancer are differentially expressed in African American and European American men. Cancer Epidemiol Biomarkers Prev. 2013 May;22(5):891-7. doi: 10.1158/1055-9965.EPI-12-1238. Epub 2013 Mar 20.
Background: PubMed 34953525Attard G, Murphy L, Clarke NW, Cross W, Jones RJ, Parker CC, Gillessen S, Cook A, Brawley C, Amos CL, Atako N, Pugh C, Buckner M, Chowdhury S, Malik Z, Russell JM, Gilson C, Rush H, Bowen J, Lydon A, Pedley I, O'Sullivan JM, Birtle A, Gale J, Srihari N, Thomas C, Tanguay J, Wagstaff J, Das P, Gray E, Alzoueb M, Parikh O, Robinson A, Syndikus I, Wylie J, Zarkar A, Thalmann G, de Bono JS, Dearnaley DP, Mason MD, Gilbert D, Langley RE, Millman R, Matheson D, Sydes MR, Brown LC, Parmar MKB, James ND; Systemic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) investigators. Abiraterone acetate and prednisolone with or without enzalutamide for high-risk non-metastatic prostate cancer: a meta-analysis of primary results from two randomised controlled phase 3 trials of the STAMPEDE platform protocol. Lancet. 2022 Jan 29;399(10323):447-460. doi: 10.1016/S0140-6736(21)02437-5. Epub 2021 Dec 23.
Background: PubMed 33321449Bebelman MP, Janssen E, Pegtel DM, Crudden C. The forces driving cancer extracellular vesicle secretion. Neoplasia. 2021 Jan;23(1):149-157. doi: 10.1016/j.neo.2020.11.011. Epub 2020 Dec 14.
Background: PubMed 27960084Becker A, Thakur BK, Weiss JM, Kim HS, Peinado H, Lyden D. Extracellular Vesicles in Cancer: Cell-to-Cell Mediators of Metastasis. Cancer Cell. 2016 Dec 12;30(6):836-848. doi: 10.1016/j.ccell.2016.10.009.
Background: PubMed 10951492Carlsson L, Pahlson C, Bergquist M, Ronquist G, Stridsberg M. Antibacterial activity of human prostasomes. Prostate. 2000 Sep 1;44(4):279-86. doi: 10.1002/1097-0045(20000901)44:43.0.co;2-2.
Background: PubMed 18369637Cooperberg MR, Cowan J, Broering JM, Carroll PR. High-risk prostate cancer in the United States, 1990-2007. World J Urol. 2008 Jun;26(3):211-8. doi: 10.1007/s00345-008-0250-7. Epub 2008 Mar 28.
Background: PubMed 10458230D'Amico AV, Whittington R, Malkowicz SB, Fondurulia J, Chen MH, Kaplan I, Beard CJ, Tomaszewski JE, Renshaw AA, Wein A, Coleman CN. Pretreatment nomogram for prostate-specific antigen recurrence after radical prostatectomy or external-beam radiation therapy for clinically localized prostate cancer. J Clin Oncol. 1999 Jan;17(1):168-72. doi: 10.1200/JCO.1999.17.1.168.
Background: PubMed 9817331D'Amico AV, Whittington R, Malkowicz SB, Fondurulia J, Chen MH, Tomaszewski JE, Wein A. The combination of preoperative prostate specific antigen and postoperative pathological findings to predict prostate specific antigen outcome in clinically localized prostate cancer. J Urol. 1998 Dec;160(6 Pt 1):2096-101. doi: 10.1097/00005392-199812010-00041.
Background: PubMed 9749478D'Amico AV, Whittington R, Malkowicz SB, Schultz D, Blank K, Broderick GA, Tomaszewski JE, Renshaw AA, Kaplan I, Beard CJ, Wein A. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA. 1998 Sep 16;280(11):969-74. doi: 10.1001/jama.280.11.969.
Background: PubMed 37891072Eapen RS, Buteau JP, Jackson P, Mitchell C, Oon SF, Alghazo O, McIntosh L, Dhiantravan N, Scalzo MJ, O'Brien J, Sandhu S, Azad AA, Williams SG, Sharma G, Haskali MB, Bressel M, Chen K, Jenjitranant P, McVey A, Moon D, Lawrentschuk N, Neeson PJ, Murphy DG, Hofman MS. Administering [177Lu]Lu-PSMA-617 Prior to Radical Prostatectomy in Men with High-risk Localised Prostate Cancer (LuTectomy): A Single-centre, Single-arm, Phase 1/2 Study. Eur Urol. 2024 Mar;85(3):217-226. doi: 10.1016/j.eururo.2023.08.026. Epub 2023 Oct 26.
Background: PubMed 7989510Fabiani R, Johansson L, Lundkvist O, Ronquist G. Enhanced recruitment of motile spermatozoa by prostasome inclusion in swim-up medium. Hum Reprod. 1994 Aug;9(8):1485-9. doi: 10.1093/oxfordjournals.humrep.a138735.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Oncology Clinical Research Referral Office contact

551-996-1777

OncologyResearchReferral@hmhn.org

Nitin Yerram, MD principal investigator

Hackensack Meridian Health

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lu-17-PSMA-617 in people with Prostate Adenocarcinoma, run by Hackensack Meridian Health at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Oncology Clinical Research Referral Office (551-996-1777, OncologyResearchReferral@hmhn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prostate cancer down-staging following treatment with Lu-177-PSMA-617 (PluvictoⓇ) defined by Gleason Grade Group (time frame: Patients will undergo a PSMA PET/CT scans up to week 11 +/- 30 days prior to radical prostatectomy with pelvic lymph node dissection.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06798558, which also lists 44 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.