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New treatment option for Prostate Adenocarcinoma
Official title Two-fraction HDR Monotherapy for Localized Prostate Cancer
ClinicalTrials.gov ID: NCT05665738
What this study is testing
- What it's testing
- 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.
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
- Participants must have histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.
- National Comprehensive Cancer Network low to intermediate risk stratification.
- No prior treatment for prostate cancer and no prior androgen deprivation therapy.
- Age \>=18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status \ 60%.
You likely can't join if
- Any prior treatment for prostate cancer.
- Any prior androgen deprivation therapy.
- Is currently receiving any other investigational agents.
- Abnormal pre-brachytherapy assessment raising concern for undergoing HDR brachytherapy procedure.
- Contraindications to general anesthesia.
- Contraindications to radiotherapy.
See the full eligibility criteria
- Participants must have histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.
- National Comprehensive Cancer Network low to intermediate risk stratification.
- No prior treatment for prostate cancer and no prior androgen deprivation therapy.
- Age \>=18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status \ 60%.
- Eligible to undergo High dose rate (HDR) brachytherapy as monotherapy as determined by the treating radiation oncologist.
- Ability to understand and the willingness to sign a written informed consent document.
- Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- 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...
- Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- Any prior treatment for prostate cancer.
- Any prior androgen deprivation therapy.
- Is currently receiving any other investigational agents.
- Abnormal pre-brachytherapy assessment raising concern for undergoing HDR brachytherapy procedure.
- Contraindications to general anesthesia.
- Contraindications to radiotherapy.
- Prior cryosurgery or cryotherapy to the prostate.
- Prior transurethral resection of the prostate within the previous 6 months.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, 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 - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.