BridgeMD
New treatment option for Prostate Adenocarcinoma
Official title High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma
ClinicalTrials.gov ID: NCT04945642
What this study is testing
- What it's testing
- This phase II trial investigates the effect of high dose-rate brachytherapy and stereotactic body radiotherapy in treating patients with prostate adenocarcinoma. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells.
- 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
- Ability to understand a written informed consent document, and the willingness to sign it
- Age \>= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration
- Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b, PSA \> 10, and/or Gleason score \>= 7
You likely can't join if
- Patients with neuroendocrine or small cell carcinoma of the prostate
- Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free...
- Regional lymph node involvement
- Evidence of distant metastases
- Previous radical surgery (prostatectomy) or cryosurgery or high-intensity focused ultrasound for prostate cancer
- Previous pelvic irradiation or prostate brachytherapy
See the full eligibility criteria
- Ability to understand a written informed consent document, and the willingness to sign it
- Age \>= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- History/physical examination with digital rectal examination of the prostate within 8 weeks prior to registration
- Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (T1c-T3b, PSA \> 10, and/or Gleason score \>= 7
- No evidence of disease beyond the prostate and/or seminal vesicles (i.e., no suspicious pelvic lymph nodes or presence of metastatic disease outside the pelvis)
- Prostate size =\< 60cc
- International Prognostic Scoring System (IPSS) score =\< 15
- Able to safely receive moderate sedation or general anesthesia
- Patients with neuroendocrine or small cell carcinoma of the prostate
- Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years
- Regional lymph node involvement
- Evidence of distant metastases
- Previous radical surgery (prostatectomy) or cryosurgery or high-intensity focused ultrasound for prostate cancer
- Previous pelvic irradiation or prostate brachytherapy
- Previous or concurrent cytotoxic chemotherapy for prostate cancer
- Patients with history of inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), high predisposition for radio-toxicity compared to general population (i.e., ataxia telangiectasia), or at risk for major...
- Transurethral resection of the prostate (TURP) procedure within 6 months of radiation treatment
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, 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 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?
Study sites include Los Angeles, 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.