A Phase II Randomized Trial of Lu-PSMA and Stereotactic Radiotherapy Versus Radiotherapy Alone for Oligometastatic Prostate Cancer (LUST)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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)

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• PSMA-PET/CT positive scan matching with lesions documented on baseline CT/MRI or WBD-MRI.

• 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.

• Patients will be admitted to the therapeutic phase only if diagnostic PET/CT PSMA SUV max is ≥ 3.

• Histologic confirmation of malignancy (primary or metastatic tumor).

• Prostate specific antigen (PSA) ≥ 0.2 ng/mL but ≤ 50 ng/mL and Testosterone ≥ 125 ng/dL.

• 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).

• Patients unfit or refusing ADT.

• 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 be ≥ 18 years of age.

⁃ Patient understands the purpose of the study and the procedures required for it; the patient is willing to participate in the study and to sign a written informed consent document.

⁃ Patients must have an Eastern Cooperative Oncology Group performance status ≤ 2.

⁃ Patients should have a life expectancy of at least 6 months.

⁃ Patients must have normal organ and marrow function as defined as:

∙ Leukocytes \>2,000/μL;

‣ Absolute neutrophil count \>1,000/μL;

‣ Platelets \>75,000/μL;

‣ total bilirubin within normal institutional limits (this will not apply to patients with confirmed Gilbert's syndrome);

‣ AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal;

‣ Creatinine within normal institutional limits.

⁃ 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.

⁃ 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.

Locations
Other Locations
Italy
UO Medicina Nucleare, AUSL della Romagna
RECRUITING
Cesena
UO Medicina Nucleare, IRCCS IRST
RECRUITING
Meldola
Contact Information
Primary
Oriana Nanni
cc.ubsc@irst.emr.it
+390543739100
Backup
Bernadette Vertogen
cc.ubsc@irst.emr.it
+390544286058
Time Frame
Start Date: 2023-06-27
Estimated Completion Date: 2032-04
Participants
Target number of participants: 70
Treatments
Experimental: Stereotactic Radiotherapy followed by Lu-PSMA (arm A)
Ablative stereotactic radiation on the metastatic sites. Delivered in a 1 to 5 fractions regimen. 177Lu-PSMA-I\&T in 2 cycles of treatment at 6-8 weekly intervals at a dosage of 7.4 Gigabequerel (GBq)
Active_comparator: Stereotactic Radiotherapy (arm B)
Ablative stereotactic radiation on the metastatic sites. Delivered in a 1 to 5 fractions regimen.
Related Therapeutic Areas
Sponsors
Leads: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

This content was sourced from clinicaltrials.gov