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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05616650
Recruitment Status : Not yet recruiting
First Posted : November 15, 2022
Last Update Posted : March 30, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Prostate Cancer Prostate Adenocarcinoma Drug: 18F-DCFPyL Radiation: Stereotactic Body Radiation Therapy Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Focal Ultrahypofractionated Stereotactic Radiation Therapy for the Treatment of Unifocal Prostate Cancer
Estimated Study Start Date : April 4, 2023
Estimated Primary Completion Date : December 1, 2027
Estimated Study Completion Date : December 1, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 1/Focal SBRT
Focal SBRT to the tumor focus within the prostate, with response assessed by biopsy and imaging, including 18F-DCFPyL PET/CT.
Drug: 18F-DCFPyL
Each participant will receive a single IV dose of 18F-DCFPyL by bolus injection. The target administered activity will be 6.5 mCi with a lower limit of 6 mCi; dose variations will be in accordance with the Nuclear Regulatory Commission (NRC) standard dose variation (i.e., 20%) permitted for diagnostic clinical studies.

Radiation: Stereotactic Body Radiation Therapy
Intensity modulated radiotherapy will be delivered to a dose of 26Gy in two fractions with the second fraction performed within 8 days of the first session.




Primary Outcome Measures :
  1. Pathologic complete response rate [ Time Frame: 2 years ]
    The primary objective of this trial is to determine the pathologic complete response rate on biopsy at two years in patients undergoing focal SBRT for prostate cancer. This will be defined by a negative biopsy at 2 years post-treatment.


Secondary Outcome Measures :
  1. Longitudinal quality of life (QoL) [ Time Frame: baseline and 1, 3, 6, 9, 12, 15, 18, 21, and 24 months after focal SBRT ]
    The QoL scores will be summarized at baseline and for each visit. Linear mixed effects model will be used to model quality of life scores at baseline, during and after treatment. Changes of QoL scores from baseline at each timepoint treatment will be calculated from the estimated linear mixed effect model.

  2. PSA kinetics [ Time Frame: 1 week and 1, 3, 6, 9, 12, 15, 18, 21, 24 months after focal SBRT ]
    The PSA kinetics scores will be summarized at baseline and for each visit. Linear mixed effects model will be used to model PSA kinetics at baseline, during and after treatment. Changes of PSA kinetics during and after treatment will be calculated from the estimated linear mixed effect model. In the rare case where PSA test is done on outside laboratory assay, a sensitivity analysis will be conducted to analyze PSA kinetics with and without outside values to determine whether outside laboratory measurement influenced results.

  3. Nadir PSA [ Time Frame: 1 week and 1, 3, 6, 9, 12, 15, 18, 21, 24 months after focal SBRT ]
    The nadir PSA (time to nadir PSA and value of nadir PSA) will be described for this cohort (median, mean, standard deviation, and range).

  4. Absolute and relative fraction of free PSA to bound PSA [ Time Frame: 1 week and 1, 3, 6, 9, 12, 15, 18, 21, 24 months after focal SBRT ]
    Descriptive statistics for the absolute amount and relative fraction of free PSA and bound PSA at the various timepoints detailed in 10.1 will be reported will be compared with baseline by paired Wilcoxon test.

  5. Toxicity profile [ Time Frame: During the focal SBRT period and 1, 3, 6, 9, 12, 18, 24 months after focal SBRT ]
    Descriptive statistics will be used to summarize the toxicity profile of focal SBRT of prostate cancer.

  6. Rate of biochemical failure [ Time Frame: 24 months after focal SBRT ]
    The rate of biochemical failure as defined by nadir PSA + 2.0 ng/mL at 24 months will be described.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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, >cT2a, 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 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 irritable 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 18FDCFPyL 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05616650


Contacts
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Contact: Theresa Cooley-Zgela, R.N. (240) 764-6207 theresa.cooleyzgela@nih.gov
Contact: Krishnan R Patel, M.D. (240) 858-3211 krishnan.patel@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Krishnan R Patel, M.D. National Cancer Institute (NCI)
Additional Information:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT05616650    
Other Study ID Numbers: 10000611
000611-C
First Posted: November 15, 2022    Key Record Dates
Last Update Posted: March 30, 2023
Last Verified: January 22, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .All collected IPD will be shared. All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data from this study may be requested from other researchers 2 years after the completion of the primary endpoint.@@@@@@If dbGaP is applicable: Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
Access Criteria: Data from this study may be requested by contacting the PI.@@@@@@Genomic data are made available via dbGaP through requests to the data custodians.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Sbrt
PSMA
Targeted Pet Imaging
Prostate Adenocarcinoma
Additional relevant MeSH terms:
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Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type