Hypofractionated Radiotherapy With a Focal Microboost for High-Risk and Locally Advanced Prostate Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 2 years
- Procedures mentioned: Blood draws, Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participation will include standard of care visits along with questionnaires and blood draws completed for research purposes."
- "Participation in this study is anticipated to last approximately 6 weeks with follow up every three months for two years then twice yearly for years 3-5."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety and effects of two radiation methods used together: larger doses given over fewer visits, plus extra radiation to a small target area. It is for adult men with untreated, high-risk prostate cancer, including cancer that has spread nearby or to lymph nodes in the pelvis.
This study is for adult men with previously untreated high risk, very high risk, or pelvic lymph node positive prostate cancer. The purpose of this study is to evaluate the safety and effectiveness of the combination of two emerging radiation treatment techniques (hypofractionated radiotherapy and microboost technique). Participation will include standard of care visits along with questionnaires and blood draws completed for research purposes. There is optional banking of blood and prostate biopsy tissue which will not require extra biopsies. Participation in this study is anticipated to last approximately 6 weeks with follow up every three months for two years then twice yearly for years 3-5.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be biologically male and age 18 or older. Sign a consent form and agree to study visits and procedures.
- Have high-risk prostate cancer with no distant spread. Signs include a PSA blood level over 20, growth outside the prostate, a Gleason score of 8–10 (a cancer grade), or cancer in pelvic lymph nodes.
- Have no past prostate cancer treatment, except certain allowed treatments. Prior TURP, surgery to remove tissue through the urine tube, is allowed if done at least 90 days before radiation.
- Be able to receive radiation to the pelvis and have a prostate or pelvic MRI. The MRI must show at least one area that meets the study rules for extra radiation.
- Be able to care for yourself and be up and about at least half of waking hours.
- Have the required exam, scans, and blood tests within 120 days before joining. Blood cell counts and liver tests must meet study limits.
- Agree to and be eligible for 12–36 months of ADT, hormone treatment that lowers testosterone.
- Use condoms or another effective birth control method with your partner during radiation and for six months afterward.
Who can't join
- Use testosterone supplements without stopping by the time you join, or have started prostate cancer hormone treatment more than 90 days before joining.
- Have scans showing cancer spread beyond the pelvic lymph nodes.
- Have had radiation to the pelvis, complete prostate removal, or treatments that destroy prostate tissue using freezing, heat, sound waves, lasers, electrical pulses, or water jets.
- Have health problems that prevent radiation aimed at curing the cancer, an expected lifespan under five years, or another condition the study doctor says prevents participation.
- Have received another experimental prostate cancer treatment within the past 12 months.
- Have had an invasive pelvic cancer, blood cancer, or lymph system cancer without being cancer-free for at least five years. Non-melanoma skin cancer is an exception.
- Have another past or current cancer that could affect the study’s safety or treatment results.
- Be unable to have small gold markers or gel placed for radiation treatment. The markers guide radiation, and the gel separates the prostate from the rectum.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Biologically male patients aged 18 years and older. 4. Ability to receive pelvic radiotherapy and be willing to adhere to the protocol regimen. 5. Previously untreated prostate cancer (with cytotoxic chemotherapy, cryotherapy, ablative treatment, surgical or radiation therapy). Prior transurethral resection of prostate (TURP) is permitted if 90 days or more prior to the start of radiotherapy. 6. Localized or locally advanced prostate cancer meeting NCCN criteria for high risk, very high risk or non-metastatic, pelvic lymph node positive defined as having at least one or more of the following: 1. PSA \>20 ng/mL prior to starting ADT. 2. cT3a-T4 by digital exam or imaging. 3. Gleason score of 8-10 (grade group 4 or 5). 4. Staged as N1M0 by the treating investigator (pelvic lymph node positive, below the aortic bifurcation) based on soft tissue imaging within 120 days prior to registration (may include CT, MRI or PSMA PET/CT, of fluciclovine choline PET/CT). 7. History and physical exam within 120 days prior to registration. 8. ECOG performance status 0-2. 9. Be able to undergo MRI of the prostate and/or pelvis as a component of RT planning. 10. Have at least one MRI visible target for microboost (PI-RADS≥ 4 version 2.0). 11. Bone and soft tissue imaging as clinically indicated for staging within 120 days prior to registration. 12. For males: use of condoms or other methods to ensure effective contraception with partner during radiation and for six months after completion of radiation. 13. Adequate hematologic function within 120 days prior to registration as defined by: 1. hemoglobin \>=9.0 g/dL independent of transfusion, and 2. platelet count \>= 100,000 x 10 \^9/microliter independent of transfusion. 14. Adequate hepatic function within 120 days prior to registration defined as total bilirubin \<2 x institutional upper limits of normal (ULN is 1.2 mg/dL). If labs are done at outside institution, total bilirubin should be \<2.4. 15. Agreeable and eligible to receive long term (defined as 12-36 months) ADT as a standard component of prostate cancer therapy. Exclusion Criteria: * 1\. Concurrent use of testosterone supplementation unless discontinued by time of registration. 2\. Definitive radiologic evidence of metastatic disease outside of the pelvic nodes on conventional imaging (bone scan, CT scan, MRI). 3\. Prior pelvic radiotherapy. 4. Pre-existing conditions or overall health status which disqualifies the patient from curative intent-RT. Patients with life expectancy less than 5 years are not eligible. 5\. Treatment with another investigational prostate cancer therapy within 12 months. 6\. Prior total prostatectomy, cryotherapy, high-intensity focused ultrasound, irreversible electroporation, MRI ablation, laser ablation, transurethral ultrasound ablation, aquablation directed towards the prostate for any prostate disease or condition. 7\. Prior or concurrent invasive pelvic malignancy (except non-melanomatous skin cancer) or lymphomatous or hematogenous malignancy, unless disease free for a minimum of 5 years. 8\. Any condition that, in the opinion of the investigator, would preclude participation in this study. 9\. Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 90 days prior to registration. 10\. Inability to undergo implantation of gold fiducial markers or rectal spacer gel. 11\. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
Study sites (1)
SC
- Medical University of South Carolina Hollings Cancer Center · Charleston, SC 29425Casey Charlton · Study contact · charltoc@musc.eduMore trials in Charleston