Radiation Therapy for Prostate Cancer

Not currently recruiting at 2 trial locations

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Alpha reductase inhibitors, ADT

Disqualifiers: Other malignancies, Severe co-morbidity, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 41

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two types of radiation treatments to determine which better improves the quality of life for men with prostate cancer that hasn't spread. One method, high-dose rate brachytherapy, involves placing a temporary radioactive seed inside the prostate. The other, stereotactic ablative radiotherapy, uses an external beam to deliver large radiation doses over five sessions. Men diagnosed with localized prostate cancer (cancer confined to the prostate) in the past nine months, who have not undergone extensive prostate treatments, may be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop using alpha reductase inhibitors at least 2 weeks before joining. You cannot use androgen deprivation therapy (ADT) during the trial. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that high-dose rate (HDR) brachytherapy for prostate cancer was well-tolerated. Patients experienced good cancer control with few side effects. This treatment involves placing a small radioactive seed in the prostate briefly, targeting the radiation and protecting nearby organs.

Research has shown that stereotactic ablative radiotherapy (SABR) is also generally safe for prostate cancer. It delivers high doses of radiation externally in just a few sessions, causing few serious side effects.

Both treatments are in a mid-phase trial, having already demonstrated some safety in earlier stages. They are still being tested to determine which one best improves quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about High-Dose Rate Brachytherapy (HDR) and Stereotactic Ablative Radiotherapy (SABR) for prostate cancer because these treatments offer precision and efficiency that differ from traditional options. HDR delivers highly concentrated radiation directly to the tumor in a shorter timeframe, minimizing exposure to surrounding healthy tissues. SABR uses advanced imaging to target the tumor with pinpoint accuracy, which allows for fewer sessions compared to conventional radiotherapy. These innovative approaches aim to reduce side effects and improve patient outcomes, making them promising alternatives to standard treatments like external beam radiation therapy.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research has shown that high-dose rate (HDR) brachytherapy, one of the treatments in this trial, effectively treats localized prostate cancer. Studies indicate it controls cancer in over 90% of cases, whether used alone or with external radiation. This treatment is generally well-tolerated and maintains disease control for many years.

Stereotactic ablative radiotherapy (SABR), another treatment option in this trial, demonstrates similar effectiveness to brachytherapy. It delivers precise, high doses of radiation in just a few sessions. Research has found that SABR effectively prevents cancer recurrence and is also well-tolerated by patients. Both treatments in this trial offer strong potential for effectively managing localized prostate cancer. ^{3 4 5 6 7}

Who Is on the Research Team?

Lara Hathout

Principal Investigator

Rutgers Cancer Institute of New Jersey

Are You a Good Fit for This Trial?

Men recently diagnosed with localized prostate cancer, having low to intermediate risk (T1-T2 stage, Gleason score ≤7, PSA <15 ng/ml), and medically fit for brachytherapy. Prostate size must be ≤60 cc and IPSS ≤20. No prior treatments like surgery or chemotherapy for prostate cancer are allowed. Men must agree to not use hormonal therapy during the trial and commit to effective contraception.

Inclusion Criteria

I am not currently on hormone therapy for cancer.

My prostate cancer is in the early or intermediate stage.

Prostate volume by trans-rectal ultrasound (TRUS) =< 60 cc

Exclusion Criteria

I am currently on IV antibiotics for a serious bacterial or fungal infection.

I am a man who agrees to use effective contraception during the study.

I do not have inflammatory bowel disease or autoimmune conditions like lupus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either high-dose rate brachytherapy or stereotactic ablative radiotherapy

1-2 weeks

5 visits (in-person) for SABR

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Periodic visits up to 36 months

What Are the Treatments Tested in This Trial?

Interventions

• High-Dose Rate Brachytherapy
• Stereotactic Ablative Radiotherapy

Trial Overview This phase II trial compares two radiation therapies: high-dose rate brachytherapy (radiation via a seed inside the prostate) versus stereotactic ablative radiotherapy (external beam radiation in few large doses). The goal is to determine which treatment offers better quality of life as reported by patients themselves.

How Is the Trial Designed?

Group I: Arm II (SABR) Experimental Treatment 3 Interventions

Patients undergo SABR every other day for 5 treatments.

Group II: Arm I (HDR) Experimental Treatment 3 Interventions

Patients undergo HDR.

High-Dose Rate Brachytherapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as High-Dose Rate Brachytherapy for:

• Prostate adenocarcinoma
• Cervical cancer
• Breast cancer
• Skin cancer

Approved in European Union as High-Dose Rate Brachytherapy for:

• Prostate adenocarcinoma
• Cervical cancer
• Breast cancer
• Skin cancer
• Esophageal cancer

Approved in Canada as High-Dose Rate Brachytherapy for:

• Prostate adenocarcinoma
• Cervical cancer
• Breast cancer

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12190164/

Long-Term Outcomes After High-Dose-Rate Brachytherapy ... These outcomes included lower biochemical recurrence-free survival at 5 and 8 years, lower OS, and lower prostate CSS compared to patients with ...

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

High-Dose-Rate Brachytherapy Boost for Prostate Cancer a single high-dose-rate (HDR) of 15 Gy combined with external radiation therapy of 40 to 50 Gy results in disease-free survival of over 90% for intermediate- ...

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

High-dose-rate brachytherapy boost for prostate cancer: A ... Overall, this study demonstrated the efficacy of EBRT-boosted brachytherapy in the treatment of intermediate- and high-risk prostate cancer, ...

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

Prostate high dose-rate brachytherapy as monotherapy for ... HDR monotherapy delivered in two fractions of 13.5 Gy demonstrated a persistent cancer control rate at 8 years and was well-tolerated. Single- ...

6. frontiersin.org frontiersin.org/journals/urology/articles/10.3389/fruro.2025.1598726/full

High-dose-rate brachytherapy lowers travel burden for men ... HDR-BT monotherapy significantly reduces the travel burden compared with EBRT for localized prostate cancer, with minimal treatment-associated toxicity.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38160102/

Safety of high-dose rate (HDR) brachytherapy for patients ... Conclusions: HDR-BT is a safe treatment for patients with prostate cancer who previously received RT for rectal cancer. Further studies are ...