RecruitingPhase 1 / Phase 2

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

STARLiT: STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer: A Phase I/II Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests Pluvicto with radiation instead of hormone-lowering therapy with radiation for prostate cancer that has grown nearby. Researchers want to see if this lowers the chance of cancer coming back while protecting quality of life. Participants receive 2 or sometimes 3 doses of Pluvicto and 5 radiation treatments over 2 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 and able to do most daily activities with little or no help.
  • Have prostate adenocarcinoma confirmed by a tissue test. This is a type of prostate cancer.
  • Have a PSMA PET/CT scan within 4 months showing strong uptake in the prostate tumor (SUVmax of at least 10). This scan looks for a marker on prostate cancer cells.
  • Have cancer in certain nearby lymph nodes, or at least 2 of these: cancer growing outside the prostate (stage cT3a or cT3b), grade group 4 or higher, or PSA blood level of at least 40 ng/mL.
  • Have blood counts and kidney and liver test results that meet study safety rules. Some people need an extra kidney test.
  • Have a urinary symptom score (IPSS) of 15 or less.
  • Be medically fit for treatment, agree to follow-up visits, and be able and willing to sign a consent form.
  • If your partner could become pregnant, agree to use condoms through 14 weeks after the last Pluvicto dose. Do not donate sperm during that time.

Who can't join

  • Cancer has spread to distant sites, including bones, organs, or lymph nodes above where the body's main artery splits in the lower belly; or the prostate is larger than 90 cc.
  • Past prostate cancer treatment, radiation to the pelvis or head and neck, or treatment with radioactive medicines.
  • Use of spironolactone or experimental drugs within 30 days before study treatment; or oral ketoconazole, estrogens, or radioactive medicines within 3 months before registration or during treatment.
  • Enrollment in another experimental drug study at the same time, within 6 months of registration.
  • Another active cancer within the past 3 years, except adequately treated skin cancer or surface-level bladder cancer; or a history of myelodysplastic syndrome or acute leukemia, which affect blood cells.
  • Current or past Crohn's disease or ulcerative colitis, which cause bowel swelling.
  • Unable to safely have or tolerate a PSMA PET scan, follow radiation safety rules at home or in the hospital, or take part safely for another reason judged by the study doctor.
  • Reduced saliva with dry mouth rated above grade 1 on the study's side-effect scale.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Participant must be ≥ 18 years of age. * ECOG performance status ≤ 1 * Histologic confirmation of prostate adenocarcinoma of the prostate * PSMA avid disease on PSMA PET/CT, where the tumor in the prostate has SUVmax ≥ 10. * PSMA PET/CT must be obtained within 4 months. * Need ≥ 1 criteria: * Node positive disease on PSMA PET/CT or conventional imaging, as defined by having any of the following: * Pelvic nodal disease (cN1) as defined by LN stations that commence at the bifurcation of the common iliac vessels * Regional nodal disease (M1a) as defined by LN stations that commence at the bifurcation of the aorta and bifurcation of the proximal inferior vena cava to the common iliac veins. * In the absence of nodal metastasis, must have ≥ 2 of the following * i. cT3a or cT3b by conventional imaging (MRI) or PSMA PET/CT * ii. Grade group ≥ 4 * iii. PSA ≥ 40 ng/mL * Adequate organ and marrow function to receive treatment: * Hemoglobin \> 10 g/dL * White blood cell (WBC) \> 3000 / mL * Absolute neutrophil count ≥ 1,500 / mcL * Platelets ≥ 100,000 / mcL * Creatinine ≤ 1.5x ULN * Estimated glomerular filtration rate (eGFR)\* \> 50 mL/min * Total bilirubin\*\* \< 2× ULN * Albumin \> 3 g/dL * Aspartate aminotransferase (AST) \< 3× ULN * \*based upon Chronic Kidney Disease- Epidemiology Collaboration (CKD-EPI) equation. Participants with estimated GFR between 50 - 60 mL/min will require a 99mTc-TPA GFR test and only participants with non-obstructive pathology will be included in the study. * \*\* Total bilirubin ≤ 2x ULN (except for participants with known Gilbert's Syndrome ≤ 3x ULN is permitted) * International Prostate Symptoms Score (IPSS) ≤ 15. * Medically fit for treatment and agreeable to follow-up. * Ability to understand and the willingness to sign a written informed consent. * Participants with partners of childbearing potential, agreement to use barrier contraceptive method (condom) and to continue its use for 14 weeks from receiving the last dose of Lu-PSMA-617. Participants must also not donate sperm for 14 weeks from receiving the last dose of Lu-PSMA-617. Exclusion Criteria: * Clinical or radiographic evidence of distant metastatic disease (M1a above aortic bifurcation, M1b, or M1c) by any imaging. Participants are allowed to M1a nodal disease that is below the aortic bifurcation. Negative PSMA PET/CT is an acceptable substitute to conventional staging. * Prostate gland size \>90 cc measured by CT, ultrasound, or MRI * Prior head and neck radiation therapy. * Prior treatment for prostate cancer (incudes chemotherapy, radiation therapy, or anti-androgen therapy). * Prohibited within 30 days prior to administration to study treatment: spironolactone and other investigational drug therapies. * Prohibited 3 months before participant registration and during administration of study treatment: oral ketoconazole, , estrogens, and radiopharmaceuticals. * History of prior pelvic radiation therapy. * Enrollment concurrently in another investigational drug study within 6 months of registration. * History of another active malignancy within the previous 3 years except for adequately treated skin cancer or superficial bladder cancer. * History of prior myelodysplastic syndrome or acute leukemia. * History of or active Crohn's disease or ulcerative colitis. * Contraindication to or inability to tolerate PSMA/PET. * Any condition that in the opinion of the investigator would preclude participation in this study. * Inability to adhere to radiation safety measures in hospital or at home * Prior treatment with radionuclide therapies, 177Lu-PSMA-617 or other * Reduced salivary gland function with baseline CTCAE Gr \> 1 dry mouth will be excluded.

Study sites (1)

OH

  • University Hospitals Cleveland Medical Center Seidman Cancer Center, Case Comprehensive Cancer Center · Cleveland, OH 44106More trials in Cleveland