Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer
High Dose Rate Brachytherapy Prior to Robotic Assisted Laparoscopic Prostatectomy With Selective Adjuvant Androgen Blockade for Localized High-risk Prostate Cancer (NEOHDR-B)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 40 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: 27 months, 2 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
- "Patients will be on the study for a total of up to 27 months, including 2-3 months on active study intervention (HDR-B with RALP 4-8 weeks post HDR-B) and potentially an additional 3 months (AAB)."
- "Study follow-ups will be performed per-protocol for up to 2 years after surgery."
- 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 high-dose radiation placed inside the prostate before robot-assisted surgery to remove it. It is for people age 40 or older with newly diagnosed, high-risk prostate cancer that has not spread and who plan to have this surgery. Some patients may also receive added hormone-blocking treatment based on a cancer risk test or cancer found in lymph nodes.
This is a Phase I/II trial evaluating the effectiveness of adding neoadjuvant HDR-B prior to RALP for HR-PCa patients with selective AAB for decipher high risk or pathologically node positive patients. Patients with newly diagnosed, histologically confirmed, non-metastatic, HR-PCa who are scheduled to receive RALP will be eligible to participate in the study.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 40 or older, with a biopsy showing prostate adenocarcinoma, a type of prostate cancer.
- Scans must show no cancer in lymph nodes or other parts of the body.
- Must have high-risk cancer: PSA of 20 or more, Gleason score of 8 or more, or stage T3a or higher. You may also qualify with at least two of these: PSA 10–19.9, Gleason score 4+3, stage T2b/T2c, or cancer in at least half of biopsy samples. PSA is a blood marker; Gleason scores and stages describe the cancer.
- Must freely sign a consent form to join.
- The study doctor must find you healthy enough for surgery and internal radiation treatment.
- Must be fully active or able to do light work despite limits on hard physical activity.
- No other invasive cancer in the past 3 years, unless cancer-free for at least 2 years. Exceptions include non-melanoma skin cancer and noninvasive cancer of the bladder or head and neck.
- No treatment to lower male hormones in the past 6 months.
Who can't join
- Scans show cancer has spread to other parts of the body.
- A doctor says anesthesia, the medicine used during surgery, would be high risk for you.
- Past radiation treatment to the pelvis.
- Prostate larger than 70 cubic centimeters on MRI or ultrasound.
- Urinary symptom score above 15, even after treatment to improve symptoms.
- Treatment to lower male hormones in the past 6 months. Finasteride is allowed only if stopped more than 3 months before joining.
- Unable or unwilling to follow the study's rules.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Subjects must have biopsy-confirmed adenocarcinoma of the prostate. 2. Subjects must have a negative bone scan and CT scan or PSMA-PET for nodal or metastatic disease. 3. Subjects must have one of the following risk factors: * PSA ≥20 and/or * Gleason score ≥8 and/or * Clinical or radiographic stage ≥T3a per AJCC (American Joint Committee on Cancer) 8th Edition Staging Manual and/or * At least two out of four of the following: PSA (Prostate Specific Antigen) 10-19.9, GS (Gleason Score) = 4+3, clinical stage = T2b/T2c, ≥50% positive biopsy cores. 4. Subjects must freely sign informed consent to enroll in the study. 5. Subjects must be medically fit to undergo surgery and HDR-B as determined by the PI. 6. Age ≥ 40 7. ECOG Performance Status (performance status is an attempt to quantify cancer patients\' general well-being and activities of daily life, scores range from 0 to 5 where 0 represents perfect health and 5 represents death): 0-1. 8. No prior invasive malignancy in the past 3-years, except non-melanomatous skin cancer unless disease free for a minimum of 2 years. Carcinoma in-situ of the bladder or head and neck region is permissible. 9. Subjects must not have had prior androgen deprivation therapy in the past 6 months. Exclusion Criteria: 1. Metastatic disease as demonstrated by bone scan, CT scan, MRI of the pelvis, or PSMA-PET. 2. Declared high-risk for anesthesia by attending cardiologist, or other physician. 3. History of prior pelvic radiation therapy. 4. Prostate gland \>70 cc as assessed by MRI or TRUS. 5. Baseline IPSS \>15 with medical optimization. 6. History of androgen deprivation therapy within the past 6 months (except finasteride if discontinued \> 3 mo. prior to enrollment). 7. Unwilling or unable to comply with the study protocol. \-
Study sites (1)
TX
- Houston Methodist · Houston, TX 77030Vivian MacDonnell, CCRP · Study contactAndrew Farach, MD · Principal investigatorMore trials in Houston