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Compares treatment options for Biochemically Recurrent Prostate Carcinoma
Official title SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma
ClinicalTrials.gov ID: NCT06205316
What this study is testing
What is Antiandrogen Therapy?
Antiandrogen Therapy is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for biochemically recurrent prostate carcinoma.
Also referred to as ADT, Androgen Deprivation Therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase III trial tests the side effects of stereotactic body radiation therapy (SBRT) compared to hypofractionated radiotherapy for treating patients with prostate adenocarcinoma that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to a limited number of sites (oligometastatic). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain).
- Phase 3: a large, late-stage study
- Time commitment: about 18 months
- Which group you join is decided by chance.
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
- Histologically confirmed prostate adenocarcinoma at the time of surgery
- Pathologic stages T2-T3b, Nx or N0-1, M0-1 as staged by the pathology report (American Joint Committee on Cancer [AJCC] Criteria 8th edition [Ed.])
- PSA post radical prostatectomy ≥ 0.1 and \< 2.0 ng/mL ≤ 90 days prior to enrollment, obtained ≥ 6 weeks after surgery
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 assessed ≤ 90 days of enrollment
- Patients must sign institutional review board (IRB) approved study specific informed consent
You likely can't join if
- Previous pelvic radiation
- Prior androgen deprivation therapy for prostate cancer and PSA ≥ 0.1 ng/mL
- Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis (non-active diverticulitis and Crohn's disease not...
- Prior systemic chemotherapy for prostate cancer
- History of proximal urethral stricture requiring dilatation
- Major medical, addictive, or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment...
See the full eligibility criteria
- Histologically confirmed prostate adenocarcinoma at the time of surgery
- Pathologic stages T2-T3b, Nx or N0-1, M0-1 as staged by the pathology report (American Joint Committee on Cancer [AJCC] Criteria 8th edition [Ed.])
- PSA post radical prostatectomy ≥ 0.1 and \< 2.0 ng/mL ≤ 90 days prior to enrollment, obtained ≥ 6 weeks after surgery
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 assessed ≤ 90 days of enrollment
- Patients must sign institutional review board (IRB) approved study specific informed consent
- Patients must complete all required pre-entry tests within the specified time frames
- Patients must be able to start treatment (ADT or radiation) ≤ 120 days of study registration
- Patients must be ≥ 18 years old
- Prostate cancer up to oligometastatic disease, up to 5 sites
- Previous pelvic radiation
- Prior androgen deprivation therapy for prostate cancer and PSA ≥ 0.1 ng/mL
- Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed)
- Prior systemic chemotherapy for prostate cancer
- History of proximal urethral stricture requiring dilatation
- Major medical, addictive, or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (Consent by legal authorized...
- History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months
- On a transplant list
- More than oligometastatic disease \> 5 metastatic sites
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Albert Lea, Minnesota, United States
- Mankato, Minnesota, United States
- Rochester, Minnesota, United States
- Eau Claire, Wisconsin, United States
- La Crosse, Wisconsin, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 18 months 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 Scottsdale, Arizona, United States; Albert Lea, Minnesota, United States; Mankato, Minnesota, United States; Rochester, Minnesota, United States; Eau Claire, Wisconsin, United States; La Crosse, Wisconsin, 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.