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Two-fraction HDR Monotherapy for Localized Prostate Cancer

Two-fraction High Dose Rate Brachytherapy as Monotherapy Delivered Three Hours Apart in Localized Prostate Cancer: A Pilot Study

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: 6 months

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
  • "Participants will be followed for 6 months after last treatment or removal from study, or until death, whichever occurs first."
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 of giving two high-dose radiation treatments inside the prostate, 3 hours apart, with no other prostate cancer treatment. It is for adults with prostate cancer that has not spread and meets the study’s risk limits.

This is a single center single arm prospective pilot study investigating the safety of high dose rate (HDR) brachytherapy as monotherapy delivered in 2 fractions 3 hours apart. HDR monotherapy has been established as safe and effective in this context, however previous studies have delivered 2 fractions on separate days, or at least 6 hours apart. Clinically, this regimen, if shown to be safe and effective in future studies, has the potential to reduce operative resources and logistical stresses on brachytherapy departments.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and have prostate adenocarcinoma confirmed by a tissue or cell test.
  • Have cancer in the study’s favorable intermediate-risk group. Risk factors include stage cT2b–cT2c, grade group 1 or 2, or a PSA blood level of 10–20. Fewer than half of routine biopsy samples must contain cancer; targeted samples do not count.
  • Be fully active or able to do light work, with an ECOG activity score below 2 and a Karnofsky score above 60%.
  • Your radiation doctor must agree that high-dose radiation inside the prostate is suitable as your only prostate cancer treatment.
  • Be able to understand and sign the consent form, and be willing and able to complete surveys about urinary symptoms.
  • If you have HIV, be on effective treatment with no virus detected on a blood test within 6 months. If you have chronic hepatitis B, no virus must be detected while on treatment, if treatment is needed.
  • If you have had hepatitis C, it must be treated and cured. You may also qualify while on treatment if no virus is detected.
  • A past or current other cancer is allowed only if it or its treatment will not affect the study’s safety or results.

Who can't join

  • Any past prostate cancer treatment, including hormone-lowering treatment or freezing treatment.
  • A past cancer in the pelvis, or past radiation treatment to the pelvis.
  • Currently taking another experimental drug.
  • A test before treatment raises safety concerns, or you cannot safely have radiation or general anesthesia, which puts you to sleep for a procedure.
  • Cancer has spread to lymph nodes or distant parts of the body.
  • Surgery through the urine passage to remove or cut prostate tissue within the past 6 months.
  • Prostate size greater than 60 cubic centimeters on ultrasound or MRI.
  • A urinary symptom survey score, called IPSS, of 15 or higher before treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Participants must have histologically or cytologically confirmed diagnosis of prostate adenocarcinoma. 2. National Comprehensive Cancer Network favorable intermediate risk stratification, defined as one or more intermediate risk factors such as cT2b - cT2c category, grade group 1 or 2, or PSA 10-20 ng/mL, and less than 50% of biopsy cores positive for carcinoma (i.e. for this trial, we will only include systematic biopsy cores, not targeted biopsy cores). 3. Age \>=18 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status \<2 (Karnofsky \>60%). 5. Eligible to undergo High dose rate (HDR) brachytherapy as monotherapy as determined by the treating radiation oncologist. 6. Ability to understand and the willingness to sign a written informed consent document. 7. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. 8. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. 9. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. 10. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. 11. Willingness and ability to complete International Prostate Symptom Score questionnaires. Exclusion Criteria: 1. Any prior treatment for prostate cancer. 2. Prior history of pelvic malignancy. 3. Any prior androgen deprivation therapy. 4. Is currently receiving any other investigational agents. 5. Abnormal pre-brachytherapy assessment raising concern for undergoing HDR brachytherapy procedure. 6. Contraindications to general anesthesia. 7. Contraindications to radiotherapy. 8. Prior history of pelvic radiotherapy. 9. Presence of lymph node or distant metastases. 10. Prior cryosurgery or cryotherapy to the prostate. 11. Prior transurethral resection of the prostate (TURP) or transurethral incision within the previous 6 months. 12. Estimated prostate volume \>60 cubic centimeters as determined by transrectal ultrasound or magnetic resonance imaging. 13. IPSS score of 15 or higher prior to treatment.

Study sites (1)

CA