High Dose-Rate Brachytherapy for Prostate Adenocarcinoma
High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma
Recruiting
N/AInterventional Study
Prostate AdenocarcinomaStage IIB Prostate Cancer American Joint Committee on Cancer (AJCC) v8Stage IIC Prostate Cancer AJCC v8Stage III Prostate Cancer AJCC v8Stage IIIA Prostate Cancer AJCC v8Stage IIIB Prostate Cancer AJCC v8Stage IIIC Prostate Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Study type
Interventional
Purpose
Treatment
Participants needed
52 (estimated)
Sponsor
Jonsson Comprehensive Cancer Center · Other
Who this trial is looking for
This trial is looking for men with specific stages of prostate cancer to test a combination of treatments. Participants will undergo two types of radiation therapy to target their cancer.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I can understand and sign a consent form.
I have been diagnosed with intermediate- to high-risk prostate adenocarcinoma.
I have no signs of cancer outside the prostate.
My prostate is not larger than 60cc.
I can safely receive sedation or anesthesia.
You may not be able to join if
I have neuroendocrine or small cell carcinoma of the prostate.
I have had another invasive cancer in the past, except skin cancer.
I have regional lymph node involvement.
I have evidence of cancer spread to other parts of the body.
I have had surgery or specific treatments for prostate cancer in the past.
I have had pelvic radiation or prostate brachytherapy before.
I have a history of inflammatory bowel disease.
I had a TURP procedure within the last 6 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radi…
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. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.
Trial Locations
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Eligibility Criteria
Inclusion 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 t…
Inclusion 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
Exclusion Criteria:
* 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 bowel surgery
* Transurethral resection of the prostate (TURP) procedure within 6 months of radiation treatment
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