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High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for the Treatment of Prostate Adenocarcinoma

Phase 2 Study of High Dose-Rate Brachytherapy and Stereotactic Body Radiotherapy for Intermediate and High Risk Localized Prostate Adenocarcinoma (HYDRA)

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: 24 months, 5 years

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
  • "After completion of study treatment, patients are followed up within 90 days, every 3 months for 24 months, and then every 6 months for up to 5 years."
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 two types of radiation for prostate adenocarcinoma, a type of prostate cancer. One places radioactive material in or near the tumor; the other aims radiation very precisely from outside the body. It is for adults with medium- to high-risk cancer that has not spread beyond the prostate or nearby glands called seminal vesicles.

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.

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

Eligibility

Who can join

  • You are 18 or older and can understand and sign a form agreeing to join the study.
  • You can care for yourself and are out of bed or a chair for at least half the day (ECOG score 0–2).
  • You had a health history review and physical exam, including a finger exam of the prostate through the rectum, within 8 weeks before signing up.
  • A tissue test confirms medium- to high-risk prostate adenocarcinoma. Listed measures include stage T1c–T3b, a PSA blood test above 10, and/or a Gleason score of 7 or higher, which rates how abnormal the cancer cells look.
  • There is no sign of cancer beyond the prostate or seminal vesicles, including no suspicious nearby lymph nodes.
  • Your prostate is no larger than 60 cubic centimeters.
  • Your score on the study's IPSS rating scale is 15 or lower.
  • You can safely receive medicine to make you sleepy or fully asleep during treatment.

Who can't join

  • You have neuroendocrine or small cell prostate cancer, which are different types of prostate cancer.
  • You have or had another invasive cancer, lymphoma, or blood cancer, unless you have been cancer-free for at least 5 years. Non-melanoma skin cancer is allowed.
  • Cancer has spread to nearby lymph nodes or distant parts of the body.
  • You had surgery to remove the prostate, freezing treatment, or high-intensity focused ultrasound for prostate cancer.
  • You had radiation to the pelvis or internal radiation to the prostate.
  • You had or are receiving cell-killing chemotherapy for prostate cancer.
  • You have inflammatory bowel disease, such as Crohn's disease or ulcerative colitis; a condition that raises the risk of harm from radiation, such as ataxia telangiectasia; or a risk of needing major bowel surgery.
  • You had a TURP procedure, which removes prostate tissue through the urine tube, within 6 months before radiation treatment.

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

Official 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 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

Study sites (1)

CA