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New treatment option for Prostate Cancer (Adenocarcinoma)
Official title Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer
ClinicalTrials.gov ID: NCT07182279
What this study is testing
What is Brachytherapy?
Brachytherapy is an investigational medicine, being studied as a potential treatment for prostate cancer (adenocarcinoma).
Also referred to as Brachytherapy pre surgery.
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 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older, men only
You may be able to join if
- people must have biopsy-confirmed adenocarcinoma of the prostate.
- people must have a negative bone scan and CT scan or PSMA-PET for nodal or metastatic disease.
- people must have one of the following risk factors:
- PSA ≥20 and/or
- Gleason score ≥8 and/or
You likely can't join if
- Metastatic disease as demonstrated by bone scan, CT scan, MRI of the pelvis, or PSMA-PET.
- Declared high-risk for anesthesia by attending cardiologist, or other physician.
- History of prior pelvic radiation therapy.
- Prostate gland \>70 cc as assessed by MRI or TRUS.
- Baseline IPSS \>15 with medical optimization.
- History of androgen deprivation therapy within the past 6 months (except finasteride if discontinued \> 3 mo. prior to enrollment).
See the full eligibility criteria
- people must have biopsy-confirmed adenocarcinoma of the prostate.
- people must have a negative bone scan and CT scan or PSMA-PET for nodal or metastatic disease.
- people 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.
- people must freely sign informed consent to enroll in the study.
- people must be medically fit to undergo surgery and HDR-B as determined by the PI.
- Age ≥ 40
- 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...
- 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.
- people must not have had prior androgen deprivation therapy in the past 6 months.
- Metastatic disease as demonstrated by bone scan, CT scan, MRI of the pelvis, or PSMA-PET.
- Declared high-risk for anesthesia by attending cardiologist, or other physician.
- History of prior pelvic radiation therapy.
- Prostate gland \>70 cc as assessed by MRI or TRUS.
- Baseline IPSS \>15 with medical optimization.
- History of androgen deprivation therapy within the past 6 months (except finasteride if discontinued \> 3 mo. prior to enrollment).
- Unwilling or unable to comply with the study protocol. \-
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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 2 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, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, 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.