Prostate Cancer study: Microboost SBRT vs Whole gland de-escalation
Official title MRI-based Focal Intraprostatic Simultaneous Integrated Boost (SIB) Intensification With De-escalated Adaptive-risk SBRT for Patients With Low to Intermediate Risk Prostate Cancer
ClinicalTrials.gov ID: NCT07644598
What this study is testing
- What it's testing
- The goal of this clinical trial is to determine the safety of stereotactic body radiation therapy (SBRT) microboost technique in patients with low to intermediate risk prostate cancer.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Patients age 18 or older.
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Patients with histologically confirmed adenocarcinoma of the prostate who have not received prior pelvic radiation therapy or prostatectomy.
- cT1-cT2a (AJCC; 8TH edition, 2017)
- Grade Group 1 (GG1)
You likely can't join if
- Patients with evidence of disease Grade Group 4 (GG4) or higher.
- Patients with PSA \>20 ng/mL.
- Patients with evidence of clinical stage T3a+ or gross extracapsular extension on the diagnostic MRI.
- Patients who received prior or concurrent androgen deprivation therapy for prostate cancer.
- Patients with more than 4 disease foci identifiable on MRI.
- Patients with evidence of metastatic disease on imaging (e.g., bone scan, PSMA PET scan, or MRI/CT scan).
See the full eligibility criteria
- Patients age 18 or older.
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Patients with histologically confirmed adenocarcinoma of the prostate who have not received prior pelvic radiation therapy or prostatectomy.
- cT1-cT2a (AJCC; 8TH edition, 2017)
- Grade Group 1 (GG1)
- PSA \<10 ng/mL
- cT2b-cT2c (AJCC; 8TH edition, 2017)
- Grade Group 2 (GG2) or Grade Group 3 (GG3)
- PSA 10-20 ng/mL
- Patients with unfavorable intermediate risk prostate cancer defined by the NCCN guidelines are recommended to undergo a PSMA (Prostate-Specific Membrane Antigen) PET, then the PSMA PET must show localized disease.
- Ability to undergo an MRI fusion biopsy;
- Prostate size \<100 cc on any diagnostic MRI;
- PIRADS (Prostate Imaging-Reporting and Data System) 4+ lesion, and/or
- PIRADS 3 lesion with evidence of grade group 2-3
- Less than or equal to 4 lesions in total allowed;
- Lesion may contact the capsular edge, "possible" extracapsular extension (ECE) permitted; \ MRI fusion biopsy is preferred but if the positive core is in the same region as the target on the MRI based on a systemic...
- Genitourinary function with a baseline score ≤20 as defined by any pre-treatment IPSS questionnaire.
- Patients are mandated to get a fiducial placement. Optional proper rectal spacer placement is recommended as determined by the treating radiation oncologist based upon whether there is overt rectal wall invasion from...
- The Social Security Administration tables: https://www.ssa.gov/OACT/STATS/table4c6.html
- The WHO's Life Tables by country: https://apps.who.int/gho/data/view.main.60000?lang=en
- The Memorial Sloan Kettering Male Life Expectancy tool: https://www.mskcc.org/nomograms/prostate
- If using a life expectancy table, life expectancy should be adjusted using the clinician's assessment of overall health as follows: best quartile of health - add 50%; worst quartile of health - subtract 50%
- With a female partner of childbearing potential who is not pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method, which together result in a failure...
- With a pregnant female partner, men must remain abstinent or use a condom during the treatment period per local and institutional guidelines to avoid potential exposure to the embryo.
- The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient.
- Patients who are able to give informed consent.
- Patients with evidence of disease Grade Group 4 (GG4) or higher.
- Patients with PSA \>20 ng/mL.
- Patients with evidence of clinical stage T3a+ or gross extracapsular extension on the diagnostic MRI.
- Patients who received prior or concurrent androgen deprivation therapy for prostate cancer.
- Patients with more than 4 disease foci identifiable on MRI.
- Patients with evidence of metastatic disease on imaging (e.g., bone scan, PSMA PET scan, or MRI/CT scan).
- The presence of a cardiac pacemaker, defibrillator, or other implanted metallic or electronic device which is considered MRI unsafe;
- Severe claustrophobia;
- Inability to lie flat for the duration of the study;
- Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of MRI;
- Any other reason as determined by the investigator or treating physician.
- Patients with an I-PSS score \>20 as defined by any pre-treatment IPSS questionnaire.
- Patients with a prior history of transurethral resection of the prostate, TURP, Urolift, or other similar trans-urethral LUTS management procedure within the last 6 months.
- Patients with a prior history of severe urethral stricture.
- Patients with a prior history of pelvic irradiation.
- Patients unable to meet dosimetric constraints
- Patients with a prior history of non-cutaneous solid malignancy within the last 5 years.
- Patients with a history of active and uncontrolled inflammatory bowel disease.
- Patients who are unable to comply with follow-up visits and treatment plans.
The study team makes the final eligibility decision.
Where it is enrolling
- Washington D.C., District of Columbia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Washington D.C., District of Columbia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.