TheranosticTrials.org

Clinical Trial · NCT05893381

Lu-PSMA and Stereotactic Radiotherapy Versus Radiotherapy Alone for Prostate Cancer (LUST)

Overview

Multicenter, open-label, parallel-group, phase II randomized study in patients with oligometastatic prostate cancer with 1-3 asymptomatic metastases of the soft tissue or bone. Eligible patients will be randomized at 1:1 ratio to Stereotactic Radiotherapy followed by Lu-PSMA (arm A) or Stereotactic Radiotherapy (arm B)

Sponsor

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Phase

Phase 2

Contacts

Bernadette Vertogen (CONTACT)

cc.ubsc@irst.emr.it

+390544286058

Federica Matteucci (PRINCIPAL_INVESTIGATOR)

Oriana Nanni (CONTACT)

cc.ubsc@irst.emr.it

+390543739100

ClinicalTrials.gov

NCT05893381

Drug / Compound

PSMA I&T

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • Patients with prostate cancer must have 1-3 asymptomatic metastatic lesions that are ≤ 5.0 cm or \< 250 cm3 documented at CT/MRI or WBD-MRI.
  • Platelets \>75,000/μL;
  • AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal;
  • If the participant engages in sexual activity with a woman of childbearing potential, a condom must be used together with another highly effective method of contraception during the Treatment Period and for 6 months after the last dose of study intervention. The participant must agree not to donate sperm for the purpose of reproduction during the Treatment Phase and for a minimum of 6 months after receiving the last dose of study intervention.
  • Patients must have had their primary tumor treated with surgery and/or radiation and previous salvage radiation to the prostate bed or pelvis is allowed.
  • Leukocytes \>2,000/μL;
  • Patients should have a life expectancy of at least 6 months.
  • Patients must have normal organ and marrow function as defined as:
  • Patients may have had prior systemic therapy and/or ADT associated with treatment of their primary prostate cancer. Patients may have had ADT associated with salvage radiation therapy.
  • Patients must have an Eastern Cooperative Oncology Group performance status ≤ 2.
  • Patients unfit or refusing ADT.
  • Creatinine within normal institutional limits.
  • Highly effective birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug. Patients and female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception, see Appendix F) starting at screening and continuing throughout the study period and for 6 months after final study drug administration. Two acceptable methods of birth control thus include Condom (barrier method of contraception) and one of the following is required ( established use of oral, or injected or implanted hormonal method of contraception by the female partner; placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner; additional barrier method like occlusive cap with spermicidal foam/gel/film/cream/suppository in the female partner; tubal ligation in the female partner; vasectomy or other procedure resulting in infertility (eg., bilateral orchiectomy), for more than 6 months.16\. Highly effective birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug. Patients and female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception, starting at screening and continuing throughout the study period and for 6 months after final study drug administration.
  • Prostate specific antigen (PSA) ≥ 0.2 ng/mL but ≤ 50 ng/mL and Testosterone ≥ 125 ng/dL.
  • PSMA-PET/CT positive scan matching with lesions documented on baseline CT/MRI or WBD-MRI.
  • Histologic confirmation of malignancy (primary or metastatic tumor).
  • total bilirubin within normal institutional limits (this will not apply to patients with confirmed Gilbert's syndrome);
  • Absolute neutrophil count \>1,000/μL;
  • Patients will be admitted to the therapeutic phase only if diagnostic PET/CT PSMA SUV max is ≥ 3.
  • PSA doubling time (PSADT) \< 15 months. PSADT will be calculated using as many PSA values that are available from time of relapse (PSA \> 0.2 ng/dL).

Exclusion

  • Participation in another clinical trial with any investigational agents within 30 days prior to study screening. A window of 3 days is permitted.
  • Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177-Lu-PSMA- I \& T or other agents used in the study.
  • Previous radiation therapy on the metastatic site.
  • Bone metastasis in a femoral bone.
  • PSMA -PET/CT scan more than 3 months.
  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. A window of 3 days is permitted.
  • Spinal cord compression or impending spinal cord compression.
  • Known HIV-positivity, whether or not symptomatic.
  • Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 3 years (except for previously treated basal cell carcinoma);
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • The participant may not enter the study if ANY of the following apply:
  • Suspected pulmonary and/or liver metastases.
  • Unable to lie flat during or tolerable SABR.
  • No more than 3 years of ADT is allowed, with the most recent ADT treatment having occurred more than 6 months prior to enrollment.