Evaluating different doses of HDR brachytherapy for early stage prostate cancer

A Phase I/II Dose-escalation Study Evaluating the Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy

This study is testing different doses of a radiation treatment for early stage prostate cancer to see which one works best and has the fewest side effects for patients.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Washington University School of Medicine (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (St Louis, Missouri)
• Trial ID: NCT03424850 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of high dose rate (HDR) brachytherapy at varying doses of 21 Gy, 23 Gy, and 25 Gy for patients with early stage prostate cancer. The study will monitor both early and late side effects associated with the treatment, providing valuable data on patient outcomes. Participants will be closely observed to determine the effectiveness of these different radiation doses in managing prostate cancer. The trial includes patients who are low-risk or favorable intermediate-risk based on specific clinical criteria.

Who should consider this trial

Good fit: Ideal candidates for this study are men aged 18 and older with histologically confirmed early stage prostate cancer who meet specific risk criteria.

Not a fit: Patients with a history of prior radiation therapy to the prostate or lower pelvis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and safer treatment option for patients with early stage prostate cancer.

How similar studies have performed: Other studies have shown promising results with HDR brachytherapy, indicating that this approach has potential for success.

Eligibility criteria

Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of early stage prostate cancer.
* Must be considered either low-risk (T1-T2a, Gleason ≤ 6, PSA \< 10 ng/mL) or favorable intermediate-risk (Gleason 3 +4 = 7, percentage of positive biopsy cores \< 50%, no more than one NCCN intermediate risk factor).
* Prior androgen deprivation therapy is allowed and may have been initiated up to 6 months prior to the date of the HDR implant. The complete duration of androgen deprivation therapy can range from 4 months to 36 months provided it has been initiated no more than 6 months prior to the date of the HDR implant.
* At least 18 years of age.
* ECOG performance status ≤ 2
* Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

* Prior radiation therapy to the prostate or lower pelvis encompassing the prostate.
* A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only.
* Currently receiving any other investigational agents.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
* Unable to undergo general, spinal or local anesthesia.
* Prior TURP with a sufficiently large defect that would compromise the integrity of the implant per clinician's assessment.

Where this trial is running

St Louis, Missouri

• Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)

Study contacts

• Principal investigator: Hiram A Gay, M.D. — Washington University School of Medicine
• Study coordinator: Hiram A Gay, M.D.

Conditions Prostate Cancer; Prostate Neoplasm