Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer
Recruiting · NCT07182279 · Interventional (participants receive a specific treatment) · Lead sponsor: The Methodist Hospital Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
40 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Subjects must have biopsy-confirmed adenocarcinoma of the prostate.
- Subjects must have a negative bone scan and CT scan or PSMA-PET for nodal or metastatic disease.
- 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.
- Subjects must freely sign informed consent to enroll in the study.
- Subjects 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 death): 0-1.
- 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.
- Subjects must not have had prior androgen deprivation therapy in the past 6 months.
Exclusion criteria
- 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.
Where it is running
1 location listed across 1 US state.
- Houston Methodist - Houston, Texas, United States