Prostate Cancer (Adenocarcinoma)Phase 1/2NCT07182279
Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer
A Phase 1/2 study testing Brachytherapy in people with Prostate Cancer (Adenocarcinoma), run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma)
- What is being tested?
- Brachytherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 14 Nov 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist
Houston, Texas, 77030
Vivian MacDonnell, CCRP
Andrew Farach, MD
About this study
Official title: High Dose Rate Brachytherapy Prior to Robotic Assisted Laparoscopic Prostatectomy With Selective Adjuvant Androgen Blockade for Localized High-risk Prostate Cancer (NEOHDR-B)
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.
Read the detailed description
Approximately, 29 cancer patients will be enrolled. Patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP.
Patients with HR-PCa who are in the upper tercile of Decipher genomic risk (≥0.85) or have pathologically node-positive disease after lymph node dissection will receive 3 months of adjuvant AAB beginning two months post-RALP, as this is SOC for this type of patient. Node positive patients will also receive adjuvant pelvic radiation as this is SOC for this type of patient.
The primary objectives of the study will be to assess the feasibility and safety of adding HDR-B prior to RALP for patients with newly diagnosed HR-PCa and to measure per-protocol treatment compliance.
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.
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Being tested
- Brachytherapy
- Keywords
- high risk prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrachytherapyDrug
Also called Brachytherapy pre surgery
All patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP. Patients with high genomic risk or node positivity will receive short course adjuvant AAB.
| Study group | Role | What they receive |
|---|---|---|
| Decipher < 0.85 | Active comparator | Patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP. Receives: Drug: Brachytherapy |
| Decipher ≥0.85 with AAB | Active comparator | Patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP. In addition, patients with high genomic risk (≥0.85) will receive AAB for 12 weeks in the adjuvant setting beginning 8 weeks post RALP. Patients will receive an androgen receptor inhibitor per treating physician discretion (darolutamide 600 mg PO BID, enzalutamide 160 mg PO QD, apalutamide 240 mg PO QD, or bicalutamide 50 mg PO QD). In addition, patients will receive either a GnRH antagonist (relugolix 360 mg PO x 1 day followed by 120 mg PO QD) or a GnRH agonist (leuprolide 22.5 mg SC once or goserelin 10.8 mg SC once). Pathologically node positive patients will receive adjuvant pelvic radiation therapy as is SOC once the patient has recovered from surgery. Receives: Drug: Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
to assess the feasibility and safety of neoadjuvant HDR-B prior to RALP
Measured: up to two years post RALP
Treatment Completion
to assess rate of treatment completion per protocol
Measured: up to two years post RALP
Secondary outcomes (7)
Change From Baseline in International Prostate Symptom Score (IPSS)
Urinary health-related quality of life will be assessed using the International Prostate Symptom Score (IPSS). The IPSS questionnaire consists of 7 questions evaluating urinary symptoms. Total scores range from 0 to 35, with higher scores indicating more severe urinary symptoms. Change from baseline will be calculated at each follow-up time point.
Measured: Baseline; 3, 6, 9, 12, 18, and 24 months after robot-assisted laparoscopic prostatectomy (RALP)
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC-26) Score
Health-related quality of life will be assessed using the Expanded Prostate Cancer Index Composite (EPIC-26), a validated questionnaire that evaluates urinary, bowel, sexual, and hormonal domains in patients with prostate cancer. Scores range from 0 to 100, with higher scores indicating better quality of life. Change from baseline will be calculated at each follow-up time point.
Measured: Baseline; 3, 6, 9, 12, 18, and 24 months after robot-assisted laparoscopic prostatectomy (RALP)
Change in Prostate-Specific Antigen (PSA)
Clinical response will be assessed by the change in serum prostate-specific antigen (PSA) levels from baseline to immediately prior to robot-assisted laparoscopic prostatectomy (RALP).
Measured: Baseline and within 2 weeks prior to RALP (4-8 weeks after HDR brachytherapy)
Radiologic Tumor Response on Multiparametric MRI (mpMRI)
Radiologic response will be evaluated using multiparametric MRI of the prostate performed at baseline and immediately prior to RALP to assess changes in tumor characteristics.
Measured: Baseline and within 2 weeks prior to RALP
Pathologic Response in Prostatectomy Specimen
Pathologic response will be assessed in the prostatectomy specimen and categorized as complete response, partial response, or no response.
Measured: At RALP (4-8 weeks after HDR brachytherapy)
Biochemical recurrence
Biochemical recurrence (BCR) will be assessed using serial serum prostate-specific antigen (PSA) measurements obtained at scheduled study visits and as clinically indicated. BCR will be defined as two consecutive PSA measurements ≥0.2 ng/mL following robot-assisted laparoscopic prostatectomy (RALP).
Measured: up to 24 months post RALP
Regional and distant metastasis
Locoregional and distant metastasis-free survival will be defined as the time from robot-assisted laparoscopic prostatectomy (RALP) to the first documented evidence of locoregional or distant metastatic disease. Metastatic disease will be assessed through scheduled or symptom-driven imaging studies, including computed tomography (CT), magnetic resonance imaging (MRI), bone scan, or positron emission tomography (PET), with biopsy confirmation when clinically indicated.
Measured: Up to 24 months after RALP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Aug 2025
- Primary completion14 Nov 2026 (estimated)
- Study completion14 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Farach, The Methodist Hospital Research Institute
- Investigators
- Andrew Farach, MD, Principal investigator, The Methodist Hospital Reseach Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182279
- Sponsor's protocol ID
- Pro00038251
- Status last verified
- Mar 2026
- First submitted
- 1 Aug 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Rate Brachytherapy Prior to Robotic Assisted Laparoscopic Prostatectomy With Selective Adjuvant Androgen Blockade for Localized High-risk Prostate Cancer (NEOHDR-B)
- ClinicalTrials.gov ID
- NCT07182279
- Acronym / sponsor ID
- Pro00038251
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Keywords
- high risk prostate cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 14 Nov 2026 (estimated)
- Study completion
- 14 Nov 2026 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately, 29 cancer patients will be enrolled. Patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP.
Patients with HR-PCa who are in the upper tercile of Decipher genomic risk (≥0.85) or have pathologically node-positive disease after lymph node dissection will receive 3 months of adjuvant AAB beginning two months post-RALP, as this is SOC for this type of patient. Node positive patients will also receive adjuvant pelvic radiation as this is SOC for this type of patient.
The primary objectives of the study will be to assess the feasibility and safety of adding HDR-B prior to RALP for patients with newly diagnosed HR-PCa and to measure per-protocol treatment compliance.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decipher < 0.85 | Active comparator | Drug: BrachytherapyPatients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP. |
| Decipher ≥0.85 with AAB | Active comparator | Drug: BrachytherapyPatients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP. In addition, patients with high genomic risk (≥0.85) will receive AAB for 12 weeks in the adjuvant setting beginning 8 weeks post RALP. Patients will receive an androgen receptor inhibitor per treating physician discretion (darolutamide 600 mg PO BID, enzalutamide 160 mg PO QD, apalutamide 240 mg PO QD, or bicalutamide 50 mg PO QD). In addition, patients will receive either a GnRH antagonist (relugolix 360 mg PO x 1 day followed by 120 mg PO QD) or a GnRH agonist (leuprolide 22.5 mg SC once or goserelin 10.8 mg SC once). Pathologically node positive patients will receive adjuvant pelvic radiation therapy as is SOC once the patient has recovered from surgery. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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.
Key exclusion criteria (8 listed)
- 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 \&gt;70 cc as assessed by MRI or TRUS.
- Baseline IPSS \&gt;15 with medical optimization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrachytherapyAlso: Brachytherapy pre surgeryAll patients will receive a single fraction of HDR-B (15Gy) 4-8 weeks prior to RALP. Patients with high genomic risk or node positivity will receive short course adjuvant AAB. | Drug | Decipher < 0.85, Decipher ≥0.85 with AAB |
Primary outcome
Incidence of Adverse Events
Time frame: up to two years post RALP
to assess the feasibility and safety of neoadjuvant HDR-B prior to RALP
Treatment Completion
Time frame: up to two years post RALP
to assess rate of treatment completion per protocol
7 secondary outcomes
Change From Baseline in International Prostate Symptom Score (IPSS)
Time frame: Baseline; 3, 6, 9, 12, 18, and 24 months after robot-assisted laparoscopic prostatectomy (RALP)
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC-26) Score
Time frame: Baseline; 3, 6, 9, 12, 18, and 24 months after robot-assisted laparoscopic prostatectomy (RALP)
Change in Prostate-Specific Antigen (PSA)
Time frame: Baseline and within 2 weeks prior to RALP (4-8 weeks after HDR brachytherapy)
Radiologic Tumor Response on Multiparametric MRI (mpMRI)
Time frame: Baseline and within 2 weeks prior to RALP
Pathologic Response in Prostatectomy Specimen
Time frame: At RALP (4-8 weeks after HDR brachytherapy)
Biochemical recurrence
Time frame: up to 24 months post RALP
Regional and distant metastasis
Time frame: Up to 24 months after RALP
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Farach, MD principal investigator
The Methodist Hospital Reseach Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Brachytherapy in people with Prostate Cancer (Adenocarcinoma), run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vivian MacDonnell, CCRP (713-441-8113, vmmacdonnell@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: up to two years post RALP). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.