NCT05616650Toboroz2. fázis

Focal Therapy With Stereotactic Body Radiation Therapy (SBRT) for Patients With a Single Prostate Tumor

A Phase II Trial of Focal Ultrahypofractionated Stereotactic Radiation Therapy for the Treatment of Unifocal Prostate Cancer

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 16.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

Background: The current standard treatment of prostate cancer is either surgery or radiation. Typically, this includes either the removal or radiation of the whole prostate gland. Many people now seek out focal therapy options to decrease the side effects of treatment. Until now, several forms of physical destruction with heat (thermal ablation), cold (cryotherapy), sound waves (HIFU), laser (FLA), and electrical energy (IRE). A new type of radiation (SBRT) may be an effective way to cure men of early-stage prostate cancer with fewer side effects than standard treatments. Objective: To see how people with untreated localized prostate cancer will respond to focal therapy with SBRT. Eligibility: People aged 18 years and older with untreated localized prostate cancer (prostate cancer which has not spread outside of the prostate gland). Design: * Participants will undergo screening including blood tests, an MRI, a PSMA PET/CT (18F-DCFPyL), and a biopsy. * Small, non-radioactive, gold seeds about the size of a grain of rice will be placed in and/or around the tumor to help target the radiation treatment. * Radiation (SBRT) will occur in 2 separate sessions about 1 week apart. No sedation is used, these sessions are painless. Each session will take about 1-2 hours. Participants can go home afterwards. * Follow-up will continue for 2 years with repeat scans (MRI and PSMA PET/CT) and blood (PSA) tests. * After two years, a biopsy will be done to understand the impact of this new treatment on prostate cancer.

Állapot (regiszter): Toboroz
Fázis (regiszter): 2. fázis
Vizsgálattípus: Beavatkozással járó
Résztvevők száma: 42 (tervezett)
Első benyújtás: 2022. nov. 11.
Kezdés: 2023. okt. 19.
Elsődleges befejezés: 2030. dec. 1.
Fő szponzor: National Cancer Institute (NCI)
Betegségek: Prosztatarák
NCT-szám: NCT05616650

Mit vállalsz

Vizsgálat típusa: Beavatkozással járó · 2. fázis
Tervezett résztvevők: 42
2023. okt. 19. és az elsődleges befejezés (2030. dec. 1.) között
1 helyszín, 1 országban
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Korábbi kezelés

Participants in whom concurrent systemic Androgen Deprivation Therapy (ADT) or chemotherapy is planned.
Participants who are receiving any other investigational agents.
Participants who have previously received curative treatment for a prior or the current diagnosis of prostate cancer.
Human immunodeficiency virus (HIV)-infected individuals who are not on effective anti-retroviral therapy. Participants on anti-retroviral therapy with undetectable viral load within the 6 months prior to registration are eligible for this trial.
Participants with HCV infection who are currently on treatment, are eligible if they have an undetectable HCV viral load at screening.
Participants with prior medical comorbidity or surgical history involving the low pelvis which is expected to confer a high risk of toxicity to the experimental radiation regimen.
History of prior radiotherapy overlapping with the intended radiation field.

Más betegség

Participants with NCCN high-risk prostate cancer features (Gleason score >=8, >cT2c, or PSA >= 20 ng/mL).
Active urinary tract infection assessed by urinalysis.
Participants with hepatitis B virus (HBV) infection who have not been treated and cured.
Participants with chronic HBV at screening must have an undetectable HBV viral load on suppressive therapy.
Participants with hepatitis C virus (HCV) infection who have not been treated and cured.
Participants with connective tissue diseases.
Participants with radiation hypersensitivity syndromes.
Ongoing active inflammatory bowel disease within the radiation field.
Unwillingness to undergo an 18F-DCFPyL PET/CT or known allergy to the 18F-DCFPyL tracer.
Uncontrolled intercurrent illness, factors, or social situations that would limit compliance with study requirements.

Laborértékek

Ineligibility or unwillingness to undergo a contrast-enhanced MRI due to inadequate renal function (eGFR < 30), severe claustrophobia, a weight above tolerance of the scanner (> 350 lbs.), a body size unable to fit into the scanner, or implanted devices incompatible with an MRI (implanted cardiac devices, surgical hardware, retained shrapnel, cerebral aneurysm clips, or other incompatible objects.

Egyéb

Participants with prostate biopsies which show >= grade group 2 adenocarcinoma determined to be outside of the radiographically visible lesion (systematic biopsies which map to a radiographically detected lesion are not an exclusion criterion).
Participants found to have pelvic or distant metastases on pre-treatment staging studies.
Participants with an AUA-SI/IPSS score > 18.
Anatomic relationship between the tumor and adjacent normal tissues judged to be unfeasible for the planned treatment by the PI.
Contraindication or inability to undergo fiducial marker implantation.

A regiszterben nem jelölt feltételek

INCLUSION CRITERIA:
Participants must have histologically confirmed, low or intermediate risk prostatic adenocarcinoma verified by biopsy (NIH Laboratory of Pathology confirmation is required).
Unifocal prostate cancer defined as a single focus of prostate cancer on MRI and PSMA PET/CT imaging which is correlated with a positive targeted biopsy.
Age >=18 years.
ECOG performance status <=2 (Karnofsky >60%).
Men must agree to use highly effective contraception with their partner (barrier method of birth control; abstinence) for the duration of study participation and up to 120 days after the last radiation treatment.
Ability of individual to understand and the willingness to sign a written informed consent document.

Életkor a regiszterben: 18 év – 120 év · Nem: csak férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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Helyszín	Város	Ország	Helyszín állapota
National Institutes of Health Clinical Center	Bethesda	Egyesült Államok	Toboroz

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