Radiation Therapy for Prostate Cancer

Recruiting at 2 trial locations

Overseen By Lauren L. Mayo, MD

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: M.D. Anderson Cancer Center

Must be taking: Androgen deprivation

Disqualifiers: Lupus, Scleroderma, Diabetes, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 3

Duration: 4.5-7 weeks

186 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a shorter, more intense form of radiation therapy, known as hypofractionated radiation therapy, is more effective and has fewer side effects than the traditional method for treating prostate cancer. The goal is to determine if delivering higher doses over a shorter period can better target and kill cancer cells. Men treated for prostate cancer with surgery and possessing certain cancer characteristics might be suitable candidates for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking advancements in prostate cancer treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that patients may receive androgen deprivation therapy for up to 24 months, so you might need to continue or adjust this treatment.

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

Research has shown that hypofractionated radiation therapy, which involves delivering higher doses of radiation in fewer sessions, is generally safe for treating prostate cancer. A large study with 9,074 men found no significant difference in cancer-free time between those who received hypofractionated radiation therapy and those who received the standard treatment. This indicates that both treatments are equally effective and safe. Another study found that patients receiving the higher daily dose experienced similar cancer control and side effects as those receiving the regular treatment. Overall, these findings support the safety and manageability of hypofractionated radiation therapy for prostate cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about hypofractionated radiation therapy for prostate cancer because it offers a shorter treatment duration compared to conventional radiation therapy. While traditional treatment involves daily sessions over seven weeks, hypofractionated therapy compresses this schedule into just 4.5 weeks, making it more convenient for patients. This approach maintains effectiveness while potentially reducing the burden of treatment and its associated side effects. By offering a more efficient protocol, it could improve patients' quality of life without compromising the treatment's success.

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

Research has shown that hypofractionated radiation therapy, which uses higher doses of radiation over a shorter period, effectively treats prostate cancer. In one study, 98% of patients survived for five years without their cancer worsening. A review of 13 studies found that this treatment works as well as traditional methods in preventing cancer recurrence. In this trial, participants in Arm II will receive hypofractionated radiation therapy over 4.5 weeks, while Arm I will involve conventional radiation therapy over 7 weeks. Additionally, hypofractionated therapy was associated with fewer urinary side effects compared to standard radiation. This treatment appears promising in effectively targeting cancer while potentially reducing side effects. ^{2 3 4 6 7}

Who Is on the Research Team?

Quynh-Nhu Nguyen

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Men aged 18+ with prostate cancer, Gleason score 6-10, and stage T2-T3M0 can join. They may have up to 5 metastatic pelvic lymph nodes and must have had a radical prostatectomy. Eligible if they've received or will receive hormone therapy for up to 24 months but no prior radiation in the target area or severe co-morbidities like lupus, uncontrolled diabetes, recent heart issues, severe liver disease.

Inclusion Criteria

I had cancer other than prostate, treated over a year ago, with no current signs of that cancer.

I have prostate cancer and had surgery to remove my prostate.

I have been on hormone therapy for prostate cancer for up to 24 months.

Exclusion Criteria

I have severe health issues or uncontrolled diabetes.

I have had radiation therapy to my prostate or nearby areas.

I have received chemotherapy before or after surgery to remove my prostate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either conventional radiation therapy daily over 7 weeks or hypofractionated radiation therapy over 4.5 weeks after standard of care surgery

4.5-7 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Follow-up at 3-6 months, then every 6-12 months

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Radiation Therapy
• Radiation Therapy

Trial Overview The trial compares two types of radiation therapy for prostate cancer: conventional (standard doses over a longer period) versus hypofractionated (higher doses over a shorter period). It aims to see which is more effective at killing tumor cells with fewer side effects.

How Is the Trial Designed?

Group I: Arm II (hypofractionated radiation therapy) Experimental Treatment 3 Interventions

Patients undergo hypofractionated radiation therapy over 4.5 weeks after standard of care surgery.

Group II: Arm I (conventional radiation therapy) Active Control 3 Interventions

Patients undergo conventional radiation therapy daily over 7 weeks after standard of care surgery.

Hypofractionated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Approved in European Union as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Approved in Canada as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

External beam radiotherapy for localized prostate cancer typically lasts about 2 months, but advancements like IMRT and IGRT have significantly reduced digestive and urinary toxicities associated with treatment.

Hypofractionated radiation therapy, which allows for fewer treatment sessions, has been shown to be as effective as conventional methods in controlling cancer and minimizing side effects, making it a strong alternative to traditional external radiotherapy and brachytherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Moderate or extreme hypofractionation and localized prostate cancer: The times are changing]. Line Krhili, S., Créhange, G., Albert-Dufrois, H., et al.[2019]

In a study of 41 hormone-naïve intermediate-risk prostate cancer patients treated with hypofractionated SBRT, the treatment resulted in a significant decrease in PSA levels from an average of 7.67 ng/mL to 0.64 ng/mL at a median follow-up of 21 months, indicating effective early clinical outcomes.

No severe toxicities (Grade 3 or 4) were observed, and while there was a temporary decline in urinary and bowel quality of life scores post-treatment, they returned to baseline levels, suggesting that SBRT is a safe option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic body radiation therapy as monotherapy for intermediate-risk prostate cancer. Ju, AW., Wang, H., Oermann, EK., et al.[2021]

In a study involving 160 prostate cancer patients, both hypofractionated radiation therapy regimens (56 Gy in 16 fractions and 67 Gy in 25 fractions) were found to be safe, with manageable levels of acute gastrointestinal and urinary toxicity.

Acute grade ≥2 gastrointestinal toxicity occurred in 26% of patients in the 56 Gy group and 20% in the 67 Gy group, indicating that both treatment schedules are effective options with acceptable safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

4 Weeks Versus 5 Weeks of Hypofractionated High-dose Radiation Therapy as Primary Therapy for Prostate Cancer: Interim Safety Analysis of a Randomized Phase 3 Trial. Fonteyne, V., Sarrazyn, C., Swimberghe, M., et al.[2022]

Hypofractionated proton therapy (HFPT) for localized prostate cancer showed a high biochemical-clinical failure-free survival rate of 93.5% after four years, indicating its efficacy as a treatment option.

The treatment was associated with low rates of acute and late toxicities, with only 3.8% experiencing significant gastrointestinal issues and 12.5% urologic issues, and no long-term negative effects on urinary or bowel health reported by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four-Year Outcomes From a Prospective Phase II Clinical Trial of Moderately Hypofractionated Proton Therapy for Localized Prostate Cancer. Grewal, AS., Schonewolf, C., Min, EJ., et al.[2020]

In a study of 41 patients with high-risk localized prostate cancer, combining whole-pelvis irradiation with a stereotactic body radiotherapy (SBRT) boost resulted in a high 4-year biochemical failure-free survival rate of 91.9%, indicating effective cancer control.

The treatment was associated with minimal toxicity, with no severe (grade 3) gastrointestinal or genitourinary side effects reported, suggesting that this approach is safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The early result of whole pelvic radiotherapy and stereotactic body radiotherapy boost for high-risk localized prostate cancer. Lin, YW., Lin, LC., Lin, KL.[2020]

In a study of 132 prostate cancer patients receiving hypofractionated radiation therapy (HFRT), the treatment was found to be feasible with low acute gastrointestinal and genitourinary toxicities, with only 4% experiencing grade 3 toxicity.

The average prostate symptom score increased during treatment but returned to near baseline levels three months after completion, indicating manageable side effects and a positive impact on quality of life post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation Therapy for Prostate Cancer Using HYpofractionation Directed by UltraSound (RAPHYDUS): A Brazilian Public Health Care System Study. Faustino, FLC., Altei, WF., Canton, HP., et al.[2022]

In a study involving 32 prostate cancer patients, adaptive radiotherapy (ART) strategies significantly improved dose distribution to critical organs, reducing bladder and rectum exposure compared to conventional image-guided radiotherapy (IGRT).

The full re-optimization approach (ART3) led to the greatest reduction in dosimetric violations, improving organ-at-risk sparing by up to 93.2%, demonstrating the importance of daily treatment plan adaptations for enhanced safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric benefits of daily treatment plan adaptation for prostate cancer stereotactic body radiotherapy. Eckl, M., Sarria, GR., Springer, S., et al.[2022]

In a phase II study involving 40 high-risk prostate cancer patients, dose-escalated hypofractionated radiotherapy (hfrt) combined with androgen suppression therapy was found to be feasible, delivering 75 Gy in 25 fractions with minimal acute gastrointestinal and genitourinary toxicities.

Only 16.6% of patients experienced grade 2 genitourinary toxicity and 12.9% experienced gastrointestinal toxicity, indicating that the treatment can be administered safely while still targeting the pelvic lymph nodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute toxicity of hypofractionated intensity-modulated radiotherapy for prostate cancer. Drodge, CS., Boychak, O., Patel, S., et al.[2018]

In a study of 112 prostate cancer patients, hypofractionated radiation therapy (RT) after radical prostatectomy resulted in moderate acute genitourinary (GU) toxicity in 36% of patients and gastrointestinal (GI) toxicity in 49%, indicating that the treatment is generally well-tolerated.

Salvage RT specifically led to a significant reduction in maximum urinary flow, suggesting that while the treatment is effective, it may have a more pronounced impact on urinary function compared to adjuvant RT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Toxicity Profiles of Hypofractionated Adjuvant and Salvage Radiation Therapy After Radical Prostatectomy: Results of a Prospective Study. Saldi, S., Bellavita, R., Lancellotta, V., et al.[2019]

In a study involving 42 prostate cancer patients treated with moderate hypofractionated radiotherapy using Helical Tomotherapy, acute toxicity was found to be acceptable, with moderate genitourinary side effects being more common than gastrointestinal ones.

The treatment did not significantly impact patients' urinary and bowel functions, indicating that moderate hypofractionation is a safe option for prostate cancer patients across different risk levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate hypofractionation and simultaneous integrated boost by helical tomotherapy in prostate cancer: monoinstitutional report of acute tolerability assessment with different toxicity scales. Ferrera, G., Mortellaro, G., Mannino, M., et al.[2018]

Hypofractionated proton therapy (PT) for prostate cancer is feasible and shows an acceptable toxicity profile, with acute gastrointestinal (GI) toxicity at 0% and acute genitourinary (GU) toxicity at 5% among 82 patients studied over a median follow-up of 42 months.

The four-year biochemical control free survival (BCFFS) rates were 85% and 86%, indicating that hypofractionated PT is as effective as conventional treatments, potentially offering patients a more efficient and cost-effective option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II study of hypofractionated proton therapy for prostate cancer. Kim, YJ., Cho, KH., Pyo, HR., et al.[2022]

Radiotherapy is a crucial treatment for prostate cancer, effective at various disease stages, and can be administered through methods like external beam radiotherapy and brachytherapy.

Higher radiation doses, particularly with moderate hypofractionation (up to 3.4 Gy per fraction), are as effective as standard doses (1.8-2 Gy), and stereotactic body radiotherapy (SBRT) offers a promising option for specific patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RADIOTHERAPY OF PROSTATE CANCER: PRIMARY RADIOTHERAPY AND RADIOTHERAPY IN DISEASE RELAPSE. Antunac, K.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5002023/

Treatment outcomes with hypofractionated high-dose ... The 5-year overall survival rate was 92%. Only 1 patient died from the disease at 48 months after treatment, giving a 5-year cancer-specific survival of 98%.

2. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-15018-7

evidence from 9074 men in 13 randomized clinical trials There was no statistically significant difference in relapse-free survival after five years of treatment between the HFRT and CFRT groups. In ...

3. dovepress.com dovepress.com/hypofractionated-radiotherapy-for-prostate-cancer-a-comparative-study--peer-reviewed-fulltext-article-CMAR

Hypofractionated Radiotherapy for Prostate Cancer Proton therapy was associated with reduced GU toxicity and more favorable early PSA kinetics, while GI toxicity outcomes were comparable.

4. uclahealth.org uclahealth.org/news/release/study-confirms-safety-and-efficacy-higher-dose-per-day

Study confirms safety and efficacy of higher-dose-per-day ... While dose-escalated MHFRT was expected to improve outcomes, the data showed no additional benefit in cancer control and a higher risk of ...

5. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(25)00034-8/abstract

Hypofractionated radiotherapy for prostate cancer (HYDRA) Hypofractionated radiotherapy for prostate cancer (HYDRA): an individual patient data meta-analysis of randomised trials in the MARCAP consortium.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12548115/

evidence from 9074 men in 13 randomized clinical trials There was no statistically significant difference in relapse-free survival after five years of treatment between the HFRT and CFRT groups. In ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1470204516301024

Articles Conventional versus hypofractionated high-dose ... Prostate cancer might have high radiation-fraction sensitivity that would give a therapeutic advantage to hypofractionated treatment.