HDR Brachytherapy for Recurrent Prostate Cancer

(F-Sharp Trial)

Not currently recruiting at 1 trial location

Overseen By Abhishek Solanki, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Loyola University

Must not be taking: Chemotherapy, Immunotherapy, others

Disqualifiers: Severe GI/GU toxicity, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a focused type of radiation treatment called HDR brachytherapy (High Dose Rate Brachytherapy) for prostate cancer that has returned after earlier radiation treatment. The goal is to assess the safety and effectiveness of this treatment in directly targeting cancerous areas while sparing healthy parts of the prostate. It is designed for individuals whose prostate cancer has returned in the prostate and nearby areas after initial radiation, and who meet specific cancer stage and treatment criteria. Participants must have a confirmed biopsy showing the cancer's return and be able to undergo general anesthesia. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for recurrent prostate cancer.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on investigational agents or have received chemotherapy or immunotherapy in the last month, you may not be eligible. It's best to discuss your specific medications with the trial team.

What prior data suggests that this technique is safe for treating recurrent prostate cancer?

Research has shown that HDR brachytherapy is a safe treatment for prostate cancer. Studies have found that it delivers high doses of radiation directly to cancer cells while protecting nearby healthy tissues. In one study, patients tolerated this treatment well. Another study found that using HDR brachytherapy for recurrent prostate cancer after previous radiation did not cause major side effects. Overall, evidence suggests that HDR brachytherapy is both safe and effective for treating recurrent prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

HDR Brachytherapy is unique because it delivers high doses of radiation directly to prostate cancer cells in a very precise manner, which minimizes damage to surrounding healthy tissue. Unlike traditional external beam radiation therapy that can require multiple sessions over several weeks, HDR Brachytherapy can target cancerous lesions in one to two sessions. Researchers are excited about its potential to effectively manage recurrent prostate cancer with fewer side effects and more convenience for patients.

What evidence suggests that HDR Brachytherapy is effective for recurrent prostate cancer?

Research shows that HDR brachytherapy, the treatment under study in this trial, is an effective option for prostate cancer. Studies indicate that patients receiving HDR brachytherapy have a high rate of disease control. For example, one study found that 75% of patients treated with HDR brachytherapy did not experience cancer recurrence after five years, compared to 61% of those who only received external beam radiation therapy. Another study reported a 97% success rate in preventing cancer from returning in the treated area with HDR brachytherapy. These findings suggest that HDR brachytherapy is a promising option for treating recurrent prostate cancer, as it delivers targeted radiation directly to the affected areas while protecting normal prostate tissue. ^{1 2 3 6 7}

Who Is on the Research Team?

Abhishek Solanki, MD

Principal Investigator

Loyola University

Are You a Good Fit for This Trial?

Men with prostate cancer that has returned after radiotherapy can join this trial. They must have had a specific initial diagnosis (Stages T1-T3a, Nx/N0, Mx/M0), an ECOG score of 0-2 indicating they are fully active or ambulatory, and an IPSS less than 20 suggesting mild to moderate urinary symptoms. A recent biopsy confirming recurrence is required. The cancer should be localized without spread to lymph nodes or bones.

Inclusion Criteria

I am on hormone therapy for my cancer and can provide the duration of this treatment.

I can take care of myself and am up and about more than half of my waking hours.

I am medically cleared to undergo surgery with general anesthesia.

Exclusion Criteria

I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.

Patients receiving any other investigational agents

I have severe gastrointestinal or urinary side effects.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive focal high-dose-rate (HDR) brachytherapy for locally recurrent prostate cancer

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• HDR Brachytherapy

Trial Overview The trial tests focal HDR Brachytherapy for recurrent prostate cancer post-radiotherapy. This technique targets the recurrent disease in the prostate with high-dose radiation while sparing healthy tissue. Radioactive material is temporarily placed in the affected area through a minimally invasive procedure and then removed.

How Is the Trial Designed?

Group I: HDR Brachytherapy Experimental Treatment 1 Intervention

HDR Brachytherapy implant, Up to 30 Gray (Gy) to target lesion in one to two fractions.

HDR Brachytherapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as HDR Brachytherapy for:

• Localized prostate cancer
• Locally advanced prostate cancer
• Recurrent prostate cancer

Approved in United States as HDR Brachytherapy for:

• Prostate cancer
• Recurrent prostate cancer

Approved in Canada as HDR Brachytherapy for:

• Localized prostate cancer
• Locally advanced prostate cancer
• Recurrent prostate cancer

Who Is Running the Clinical Trial?

Loyola University

Lead Sponsor

Trials

161

Recruited

31,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6043748/

High dose-rate brachytherapy in the treatment of prostate cancer In summary, HDR brachytherapy boost results in a high disease control rates for men with localized prostate cancer, with strong evidence that it provides ...

2. advancesradonc.org advancesradonc.org/article/S2452-1094(25)00148-4/fulltext

High-Dose-Rate Brachytherapy Boost for Prostate Cancer Results showed a 5-year recurrence-free survival of 75% for the HDR-BT boost group versus 61% for the EBRT alone group.

3. thegreenjournal.com thegreenjournal.com/article/S0167-8140(24)00651-0/fulltext

Prostate high dose-rate brachytherapy as monotherapy for ... We report on the efficacy of a randomized Phase II trial comparing HDR monotherapy delivered as 27 Gy in 2 fractions vs. 19 Gy in 1 fraction with a median ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2452109425001484

High-dose-rate brachytherapy boost for prostate cancer: A ... This study reports BPFS of 85.7%, local relapse-free survival of 97%, distant MFS of 97.6% and OS of 77.6%20.

5. link.springer.com link.springer.com/article/10.1007/s11604-024-01621-4

Long-term outcomes of high-dose-rate brachytherapy and ... Our study demonstrated that HDR-BT in combination with EBRT without additional HT resulted in 7-year bFFF, CSS, and OS rates of 74.2, 100, and ...

6. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-13918-2

Long-term outcomes of salvage high-dose-rate brachytherapy ... Salvage HDR-BT without ADT is a safe and effective treatment option for localized prostate cancer recurrence after definitive radiation therapy.

7. mdpi.com mdpi.com/2227-9059/13/6/1310

Long-Term Outcomes After High-Dose-Rate Brachytherapy ... The 24-year outcomes support the viability and therapeutic efficacy of EBRT combined with a conformal HDR-BT boost for patients with VHR PCa.