Radiation Therapy for Prostate Cancer

Overseen By Kathy Lauer, BA

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Prior pelvic irradiation, prior rectal surgery, nodal or distant disease, others

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

Compensation: Varies

Number of Visits: 5

31 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treating prostate cancer by combining two types of radiation therapy. The goal is to determine if this combination is safe and well-tolerated. The treatment includes external radiation and a boost of internal radiation (brachytherapy), where a small device delivers high doses directly to the tumor. The trial seeks men with intermediate to very high-risk prostate cancer who are ready for this specific type of internal radiation as part of their care. Those who have had previous pelvic radiation or certain prostate surgeries may not qualify.

As an unphased trial, this study allows patients to contribute to innovative research that could lead to new treatment options.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these radiation therapy methods are safe for prostate cancer?

Studies have shown that techniques like ePUHRT, which protect the urethra, can help reduce urinary problems in prostate cancer patients receiving radiation. Patients may experience fewer urination issues after treatment. Some research, however, shows mixed results for short-term urinary symptoms, but these symptoms are not worse than those with traditional radiation methods.

Another study on similar treatments found that severe urinary side effects were rare in the long term. This suggests that ePUHRT is generally safe for treating prostate cancer, particularly concerning urinary side effects.

Overall, these findings suggest that ePUHRT is well-tolerated with manageable side effects, based on current research. However, it is important to monitor for any side effects and discuss them with a doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ePUHRT for prostate cancer because it offers a potentially more efficient and patient-friendly approach. Unlike traditional radiation therapy, which often involves numerous sessions, ePUHRT condenses treatment into just five fractions of 5Gy, along with a single high-dose-rate (HDR) boost of 15Gy. This method not only reduces the number of hospital visits but could also improve patient convenience and comfort without compromising effectiveness. By exploring this non-inferiority approach, researchers hope to maintain or enhance treatment outcomes while minimizing the burden on patients.

What evidence suggests that combining ePUHRT and Brachytherapy Boost is effective for prostate cancer?

Research has shown that using both external beam radiation therapy and a high-dose-rate brachytherapy boost can effectively treat prostate cancer. In this trial, participants will receive ePURT, which involves 5Gy x 5 fractions with a single HDR boost of 15Gy. Studies have found that this combination leads to positive results, including long-term cancer control. Patients receiving these treatments often experience lower chances of cancer recurrence. Additionally, these therapies help maintain survival rates over several years. Reports indicate that this method can be gentler on the urinary system compared to other radiation treatments. Overall, combining these radiation therapies appears promising for managing prostate cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Omar Ishaq, MD

Principal Investigator

Indiana University Simon Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with prostate cancer. Participants should be suitable for radiation therapy, but specific inclusion and exclusion criteria are not provided in the details given.

Inclusion Criteria

I am able to care for myself but may not be able to do active work.

I am planning to have a high dose radiation treatment for my prostate.

My colon cancer screening is current according to American Cancer Society guidelines.

Exclusion Criteria

My prostate symptoms are severe despite treatment.

I have had radiation therapy to my pelvic area before.

My tests show cancer has spread to my lymph nodes or other areas.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive ePUHRT 5Gy x 5 fractions with a single HDR boost of 15Gy

2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for acute grade ≥ 2 GI and GU toxicity post-treatment

3 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Brachytherapy Boost
• ePUHRT

Trial Overview The study is testing a combination of two radiation therapies: ePUHRT (external beam radiotherapy) at high doses over five sessions, followed by a single High Dose Rate Brachytherapy Boost, which involves implanting a radioactive source inside or next to the tumor area.

How Is the Trial Designed?

Group I: ePURT 5Gy x 5 fractions with single HDR boost of 15Gy Experimental Treatment 1 Intervention

Single arm non-randomized non-inferiority study exploring tolerability of ePURT 5Gy x 5 fractions delivered on noncontiguous weekdays with single HDR boost of 15Gy.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

Adjuvant external beam radiation therapy (AXRT) showed a higher 5-year disease-free survival rate of 61.3% compared to 36.3% for salvage external beam radiation therapy (SXRT), indicating that AXRT may be more effective for patients after radical prostatectomy.

However, 26% of patients experienced worsened continence after radiation therapy, highlighting a potential side effect of treatment that could impact quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External beam radiation therapy after radical prostatectomy: efficacy and impact on urinary continence. Petroski, RA., Warlick, WB., Herring, J., et al.[2022]

In a review of 21 randomized controlled trials involving 9040 patients with nonmetastatic prostate cancer, it was found that acute adverse events (AEs) were primarily reported by clinicians, while patient-reported outcomes (PROs) were underutilized, especially for late AEs.

The study highlights a gap in incorporating patient perspectives in reporting AEs related to radical radiation therapy, suggesting a need for standardized PRO assessments to better capture patient experiences and improve treatment evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute and Late Adverse Events Associated With Radical Radiation Therapy Prostate Cancer Treatment: A Systematic Review of Clinician and Patient Toxicity Reporting in Randomized Controlled Trials. Holch, P., Henry, AM., Davidson, S., et al.[2022]

In a study of 133 patients with localized prostate cancer, those who underwent intensity-modulated radiation therapy (IMRT) experienced better long-term health-related quality of life (HRQOL) outcomes compared to those who received three-field conformal radiotherapy (3DCRT), particularly in bowel function and sexual function.

At 60 months post-treatment, the 3DCRT group reported significantly worse bowel function and lower sexual function compared to their baseline scores, while the IMRT group maintained stable HRQOL scores, indicating that IMRT may be a safer and more effective option for preserving quality of life after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year follow-up of health-related quality of life after intensity-modulated radiation therapy for prostate cancer. Namiki, S., Ishidoya, S., Ito, A., et al.[2022]

Radical radiotherapy is effective for treating localized prostate cancer, with 85% of patients remaining free of local recurrence after 10 years, especially in those with negative lymph nodes.

Increasing the radiation dose can improve local control of the disease, but it may also lead to more side effects; new techniques like conformal radiotherapy and combined treatments with androgen deprivation are being studied to enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiotherapy of prostate cancer: established results and new developments. Dearnaley, DP.[2019]

In a study of 213 prostate cancer patients, those receiving androgen deprivation therapy (ADT) alongside radiation therapy (RT) reported significantly lower scores in sexual function and hormonal vitality compared to those receiving RT alone, indicating a negative impact on quality of life.

Factors such as lower education levels and the presence of depression further worsened the quality of life scores, highlighting the need for targeted support and interventions for patients undergoing combined therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Androgen Deprivation Therapy on Sexual and Hormonal Function in Patients Receiving Radiation Therapy for Prostate Cancer. Kushnir, T., Gofrit, ON., Elkayam, R., et al.[2016]

In a study involving 78 patients with localized prostate cancer, ultrahypofractionation (UHF) radiation therapy was found to be well tolerated, showing no significant differences in severe toxic effects compared to moderate hypofractionation (MHF) after 6 months.

Both UHF and MHF treatments resulted in similar quality of life outcomes, indicating that UHF is a safe alternative to MHF without compromising patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Toxicity of Ultrahypofractionation Compared With Moderate Hypofractionation in Prostate Cancer Treatment: A Randomized Trial. Kwan, W., Bahl, G., Kim, D., et al.[2022]

Intensity-modulated radiotherapy (IMRT) combined with brachytherapy results in significantly lower acute urinary toxicities and better quality of life (QOL) ratings compared to three-dimensional conformal radiotherapy (3D-CRT) in prostate cancer patients, based on a study of 812 patients with at least 1 year of follow-up.

IMRT also leads to a lower incidence of Grade ≥ 2 rectal bleeding (7% vs. 11% for 3D-CRT), indicating a safer profile for patients undergoing this treatment combination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy causes fewer side effects than three-dimensional conformal radiotherapy when used in combination with brachytherapy for the treatment of prostate cancer. Forsythe, K., Blacksburg, S., Stone, N., et al.[2015]

A systematic review of 40 studies found that combining external beam radiotherapy (EBRT) with high-dose rate (HDR) brachytherapy (EBTI) provides superior biochemical control and overall survival for prostate cancer patients.

Specifically, the risk of biochemical recurrence and overall survival was significantly better with EBTI compared to EBRT and EBSeeds, with hazard ratios indicating a 40% and 50% increased risk of recurrence and mortality, respectively, for EBRT compared to EBTI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of three radiotherapy modalities on biochemical control and overall survival for the treatment of prostate cancer: a systematic review. Pieters, BR., de Back, DZ., Koning, CC., et al.[2018]

In a study of 716 patients who experienced a rise in PSA after radical prostatectomy, early salvage radiation therapy (eSRT) was found to significantly improve cancer control, especially when administered at PSA levels ≤ 0.5 ng/ml.

The effectiveness of eSRT was notably higher in patients with at least two adverse pathologic features, where the risk of biochemical recurrence increased with higher PSA levels, indicating that PSA level is a critical factor in determining treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Optimal Timing for Early Salvage Radiation Therapy in Patients with Prostate-specific Antigen Rise After Radical Prostatectomy. Fossati, N., Karnes, RJ., Cozzarini, C., et al.[2022]

In a study comparing 253 patients treated with ultrahypofractionated radiotherapy (UHF) and 499 patients with dose-escalated conventional to moderate hypofractionated radiotherapy (DeRT), high-dose UHF was associated with higher rates of late gastrointestinal and genitourinary toxicity compared to both low-dose UHF and DeRT.

Despite the increased toxicity with high-dose UHF, both low-dose UHF and DeRT showed similar efficacy in terms of biochemical failure-free survival rates, suggesting that low-dose UHF (EQD2 ≤ 100 Gy1.5) is a promising treatment option with a favorable balance of safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrahypofractionated Radiotherapy versus Conventional to Moderate Hypofractionated Radiotherapy for Clinically Localized Prostate Cancer. Yamazaki, H., Suzuki, G., Aibe, N., et al.[2022]

Modern radiation techniques, such as intensity-modulated radiation therapy (IMRT), have significantly reduced the incidence of late rectal bleeding in prostate cancer patients, with rates dropping from over 20% in conventional radiotherapy to just a few percentage points.

As treatment doses increase, there is a noted rise in urological toxicities, highlighting the need for a comprehensive quality of life assessment that considers not only rectal bleeding but also urinary incontinence and impotence, especially in older patients who are living longer after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transitioning from conventional radiotherapy to intensity-modulated radiotherapy for localized prostate cancer: changing focus from rectal bleeding to detailed quality of life analysis. Yamazaki, H., Nakamura, S., Nishimura, T., et al.[2022]

External beam radiotherapy (EBRT) for loco-regional prostate cancer shows comparable 10-year survival rates to radical prostatectomy, with survival rates of 90-95% for T1, 60-70% for T2, and 50-60% for T3 stages, indicating its effectiveness as a treatment option.

Advancements in radiotherapy techniques, such as 3D-conformal RT and intensity-modulated RT (IMRT), allow for higher radiation doses to be delivered to the tumor while minimizing damage to surrounding tissues, and the use of cytoprotection with amifostine may help reduce radiation side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External beam radiotherapy for prostate cancer: current position and trends. Koukourakis, MI., Touloupidis, S.[2006]

External beam radiotherapy (EBRT) is an effective treatment for prostate cancer (PC), which is known to respond well to radiation therapy.

The review discusses current and emerging indications for EBRT in prostate cancer treatment, highlighting recent advancements that may enhance its application in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developments in external beam radiotherapy for prostate cancer. Lumen, N., Ost, P., Van Praet, C., et al.[2018]

Eosinophilic, polymorphic, and pruritic eruption associated with radiotherapy (EPPER) is a rare but significant late toxicity that can occur in patients receiving radiation and hormonal therapy for prostate cancer, as demonstrated in two case reports.

Early diagnosis and treatment of EPPER with corticotherapy can lead to full recovery without the need to interrupt ongoing cancer treatment, highlighting the importance of recognizing this condition in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eosinophilic, polymorphic, and pruritic eruption associated with radiation therapy in two patients diagnosed with prostate cancer. Barbu, MA., Anghel, RM., Ricu, G., et al.[2023]

Citations

1. 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 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1538472121004554

Patient-reported outcomes after Low-dose-rate versus High ... This study demonstrates that men with localized prostate cancer undergoing combination EBRT plus brachytherapy boost had less severe urinary toxicity following ...

3. brachyjournal.com brachyjournal.com/article/S1538-4721(25)00117-5/fulltext

High-dose-rate (HDR) brachytherapy boost in combination ... Clinical outcome in patients with prostate cancer treated with external beam radiotherapy and high dose-rate iridium 192 brachytherapy boost: a 6-year follow–up.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11930011/

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

5. tro.amegroups.org tro.amegroups.org/article/view/6981/html

Can patients with recurrent high-risk prostate cancer after ... Can patients with recurrent high-risk prostate cancer after external beam radiotherapy (EBRT) be salvaged by low dose rate (LDR) brachytherapy: case report ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11751415/

Urethra-sparing prostate cancer radiotherapy Urethra-sparing is a promising technique for the mitigation of urinary toxicity in prostate cancer patients undergoing EBRT, particularly ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2773160X25000078

The effectiveness and safety of stereotactic body ... The data on urinary symptoms revealed mixed results, with no significant differences between SBRT and CFRT in the short term. However, longer-term follow-ups ...

8. ctro.science ctro.science/article/S2405-6308(25)00085-0/fulltext

Urethral and bladder dosimetry and urinary toxicity in ... Dosimetric study of 349 patients shows IPB is feasible and safe for localized prostate cancer treatment. •. Grade ≥3 late urinary toxicity was ...

9. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.984917/full

Health-related quality of life of salvage prostate ... Results: Median follow-up was 44 months (IQR, 18-60). The actuarial 3- and 4-year biochemical relapse free survival was 53.4% and 47.5%, ...

10. acsearch.acr.org acsearch.acr.org/docs/69350/ET

Definitive External Beam Irradiation in Stage T1 and T2 ... 5-year bNED rate for all patients was 61% and 57% at 7 years. In the group with pretreatment PSA <10 ng/mL, the 5-year.