Radiation Therapy for Prostate Cancer

Overseen By Nikki Barrow, 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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the tolerability and toxicity of combining two radiation therapy methods for prostate cancer: Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT), which is an external beam radiotherapy with High Dose Rate Brachytherapy Boost (form of internal radiation where a cancer doctor implants a small plastic tube or balloon (catheter) in the tumor).

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 data supports the effectiveness of the treatment Brachytherapy Boost, ePUHRT for prostate cancer?

The use of interstitial high-dose rate implants to boost the prostate after an initial course of external beam radiotherapy (EBRT) has been applied successfully, improving results obtained with EBRT alone. Additionally, intensity-modulated radiotherapy (IMRT) combined with brachytherapy causes fewer side effects than three-dimensional conformal radiotherapy (3D-CRT), suggesting a potential benefit in using advanced radiation techniques. ^{1 2 3 4 5}

Is radiation therapy for prostate cancer generally safe for humans?

Radiation therapy for prostate cancer can cause some side effects, such as skin reactions and gastrointestinal or urinary issues, but these are often manageable. Modern techniques like intensity-modulated radiation therapy (IMRT) have reduced severe side effects, although some risks remain, especially with higher doses. ^{6 7 8 9 10}

How is the ePUHRT treatment for prostate cancer different from other treatments?

The ePUHRT treatment for prostate cancer is unique because it may involve advanced radiation techniques like 3D-conformal RT and intensity-modulated RT (IMRT), which allow for higher doses of radiation to be focused on the tumor while minimizing exposure to surrounding healthy tissues. This approach can potentially improve local control rates and reduce side effects compared to traditional radiation therapies. ^{1 11 12 13 14}

Research Team

Omar Ishaq, MD

Principal Investigator

Indiana University Simon Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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) 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]

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]

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]

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]

References

1. Greece pubmed.ncbi.nlm.nih.gov

External beam radiotherapy for prostate cancer: current position and trends. [2006]

2. United States 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. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Five-year follow-up of health-related quality of life after intensity-modulated radiation therapy for prostate cancer. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. Israel pubmed.ncbi.nlm.nih.gov

Impact of Androgen Deprivation Therapy on Sexual and Hormonal Function in Patients Receiving Radiation Therapy for Prostate Cancer. [2016]

6. England pubmed.ncbi.nlm.nih.gov

Eosinophilic, polymorphic, and pruritic eruption associated with radiation therapy in two patients diagnosed with prostate cancer. [2023]

7. United States 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Acute Toxicity of Ultrahypofractionation Compared With Moderate Hypofractionation in Prostate Cancer Treatment: A Randomized Trial. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Ultrahypofractionated Radiotherapy versus Conventional to Moderate Hypofractionated Radiotherapy for Clinically Localized Prostate Cancer. [2022]

10. England 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. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Developments in external beam radiotherapy for prostate cancer. [2018]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Assessing the Optimal Timing for Early Salvage Radiation Therapy in Patients with Prostate-specific Antigen Rise After Radical Prostatectomy. [2022]

13. Ireland 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. [2018]

14. England pubmed.ncbi.nlm.nih.gov

External beam radiation therapy after radical prostatectomy: efficacy and impact on urinary continence. [2022]