STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Angela Y. Jia, MD PhD
Study ID
NCT06574880
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Locally Advanced Prostate Cancer
  • Malignant Neoplasm of Prostate

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lu-PSMA-617 — DRUG
    Lu-PSMA will be administered at a fixed dose of 7.4GBq per cycle, on a dose escalation schedule: * Level 0: Lu-PSMA-617 for 1 cycle, followed 6 weeks later by SBRT. * Level 1 (Starting Dose Level): Lu-PSMA-617 for 1 cycle, followed 6 weeks later by SBRT, followed 6 weeks later by cycle 2. * Level 2: Lu-PSMA-617 for 1 cycle, followed 6 weeks later by SBRT, followed 6 weeks later by cycle 2, followed 6 weeks later by cycle 3.
  • 5-fraction Stereotactic Body Radiation Therapy (SBRT) — RADIATION
    Prostate and nodal SBRT will begin at the completion of cycle 1 (6 weeks after the first Lu-PSMA-617 infusion, ± 4 weeks).

Study Details

The goal of this clinical trial is to is to investigate if it is possible to lower the chance of cancer reoccurrence and also preserve quality of life by using the drug Pluvicto instead of androgen-deprivation therapy to the usual radiation therapy for advanced local prostate cancer. Participants will receive one dose of Pluvicto, followed by radiation about 6 weeks later. Radiation therapy will be completed in 5 treatments over the period of 2 weeks. A second dose of Pluvicto will be given 6 weeks after radiation is complete. Some participants may also receive a third dose of Pluvicto, and this would be given 6 weeks after the second dose of Pluvicto.

Key Dates

Start date
May 13, 2025
Status verified
Apr 2026
Primary completion
Sep 1, 2026
Completion
Mar 1, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lu-PSMA-617 + SBRT
    * Lu-PSMA-617: 7.4GBq intravenous infusion once with cycle 1, followed by 7.4GBq cycle 2 that is delivered 6 weeks after SBRT , and potentially 7.4GBq cycle #3 delivered 6 weeks after cycle #2 pending dose escalation * Radiation therapy: 5 fractions to prostate and elective nodal irradiation, SBRT, delivered 6 weeks after cycle 1 of 177Lu-PSMA-617

Primary Outcome Measure

Phase I: Maximum tolerated dose (MTD) of Lu-PSMA-617 [ Time Frame: 4 weeks after final dose of treatment (treatment expected to last up to six months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical Center Seidman Cancer Center, Case Comprehensive Cancer CenterClevelandOhio44106-

Find similar trials in Cleveland, OH

By research site
University Hospitals Cleveland Medical Center Seidman Cancer Center, Case Comprehensive Cancer Center· Cleveland, OH

Related Studies