Prostate Cancer Clinical Trial

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

Summary

Background:

Prostate cancer is the most common cancer among American men.
The best current validated treatment options include whole gland radiotherapy and radical prostatectomy.
Based on recent advances in imaging, focal ablative therapies are under investigation in attempts to deliver comparable rates of tumor control with less side effects.
Thus far, focal therapies such as cryotherapy, high-intensity focused ultrasound, or focal laser ablation have resulted in poor local control with the exception of implanted radiation sources which have shown in-field control rates > 90%.
As such, the proposed trial is designed to investigate the efficacy of a novel form of focal stereotactic body radiation therapy (SBRT) for the treatment of localized, unifocal prostate cancer.
Prostate specific membrane antigen (PSMA) targeted PET imaging was recently FDA approved for imaging men with suspected prostate cancer metastases who are potentially curable by radiation or surgery. 18F-DCFPyL, a second generation PSMA PET agent that binds with high affinity to PSMA yet clears rapidly from the blood pool will be used in this study.

Objective:

-To determine whether localized, tumor-directed SBRT can produce biopsy-confirmed tumor response at 24 months in participants with unifocal prostatic adenocarcinoma.

Eligibility:

Histologically confirmed, low or intermediate risk prostatic adenocarcinoma verified by biopsy.
Unifocal prostate cancer defined as a single focus of prostate cancer on imaging which is correlated with a positive targeted biopsy.
Age >= 18.
No concurrent systemic Androgen Deprivation Therapy (ADT) is planned.

Design:

This is a single-arm phase II trial designed to measure the efficacy of a novel application of SBRT guided with advanced prostate-specific imaging techniques.
Participants will initially undergo a treatment planning CT, multiparametric MRI (mpMRI), 18F-DCFPyL PET/CT imaging, a biopsy, quality of life (QoL) questionnaires and laboratory evaluations. SBRT will be administered at 26Gy in two fractions on two separate days.
Following completion of treatment, participants will be followed for up to 2 years through clinical evaluation, laboratory evaluations (including a complete blood count (CBC), prostate specific antigen (PSA) and testosterone measurements), QoL assessments, mpMRI, 18FDCFPyL PET/CT imaging, and a biopsy.
The accrual ceiling is set to 42 participants with the goal of recruiting 30 evaluable

participants.

View Full Description

Full Description

Background:

Prostate cancer is the most common cancer among American men.
The best current validated treatment options include whole gland radiotherapy and radical prostatectomy.
Based on recent advances in imaging, focal ablative therapies are under investigation in attempts to deliver comparable rates of tumor control with less side effects.
Thus far, focal therapies such as cryotherapy, high-intensity focused ultrasound, or focal laser ablation have resulted in poor local control with the exception of implanted radiation sources which have shown in-field control rates > 90%.
As such, the proposed trial is designed to investigate the efficacy of a novel form of focal stereotactic body radiation therapy (SBRT) for the treatment of localized, unifocal prostate cancer.
Prostate specific membrane antigen (PSMA) targeted PET imaging was recently FDA approved for imaging men with suspected prostate cancer metastases who are potentially curable by radiation or surgery. 18F-DCFPyL, a second generation PSMA PET agent that binds with high affinity to PSMA yet clears rapidly from the blood pool will be used in this study.

Objective:

-To determine whether localized, tumor-directed SBRT can produce biopsy-confirmed tumor response at 24 months in participants with unifocal prostatic adenocarcinoma.

Eligibility:

Histologically confirmed, low or intermediate risk prostatic adenocarcinoma verified by biopsy.
Unifocal prostate cancer defined as a single focus of prostate cancer on imaging which is correlated with a positive targeted biopsy.
Age >= 18.
No concurrent systemic Androgen Deprivation Therapy (ADT) is planned.

Design:

This is a single-arm phase II trial designed to measure the efficacy of a novel application of SBRT guided with advanced prostate-specific imaging techniques.
Participants will initially undergo a treatment planning CT, multiparametric MRI (mpMRI), 18F-DCFPyL PET/CT imaging, a biopsy, quality of life (QoL) questionnaires and laboratory evaluations. SBRT will be administered at 26Gy in two fractions on two separate days.
Following completion of treatment, participants will be followed for up to 2 years through clinical evaluation, laboratory evaluations (including a complete blood count (CBC), prostate specific antigen (PSA) and testosterone measurements), QoL assessments, mpMRI, 18FDCFPyL PET/CT imaging, and a biopsy.
The accrual ceiling is set to 42 participants with the goal of recruiting 30 evaluable participants.

View Eligibility Criteria

Eligibility Criteria

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.

EXCLUSION CRITERIA:

Participants with NCCN high-risk prostate cancer features (Gleason score >=8, >cT2c, or PSA >= 20 ng/mL).
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 in whom concurrent systemic Androgen Deprivation Therapy (ADT) or chemotherapy is planned.
Participants who are receiving any other investigational agents.
Participants found to have pelvic or distant metastases on pre-treatment staging studies.
Participants with an AUA-SI/IPSS score > 18.
Participants who have previously received curative treatment for a prior or the current diagnosis of prostate cancer.
Active urinary tract infection assessed by urinalysis.
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 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 HCV infection who are currently on treatment, are eligible if they have an undetectable HCV viral load at screening.
Anatomic relationship between the tumor and adjacent normal tissues judged to be unfeasible for the planned treatment by the PI.
Participants with connective tissue diseases.
Participants with radiation hypersensitivity syndromes.
Ongoing active inflammatory bowel disease within the radiation field.
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.
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.
Unwillingness to undergo an 18F-DCFPyL PET/CT or known allergy to the 18F-DCFPyL tracer.
Contraindication or inability to undergo fiducial marker implantation.
History of prior radiotherapy overlapping with the intended radiation field.
Uncontrolled intercurrent illness, factors, or social situations that would limit compliance with study requirements.

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

42

Study ID:

NCT05616650

Recruitment Status:

Recruiting

Sponsor:

National Cancer Institute (NCI)

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There is 1 Location for this study

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National Institutes of Health Clinical Center
Bethesda Maryland, 20892, United States More Info
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
Contact
888-624-1937

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

42

Study ID:

NCT05616650

Recruitment Status:

Recruiting

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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