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

Trial Summary

What is the purpose of this trial?

This phase III trial studies how well hypofractionated radiation therapy works compared to the conventional one in treating patients with prostate cancer. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.

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.

What data supports the effectiveness of this treatment for prostate cancer?

Research shows that hypofractionated radiotherapy, including techniques like intensity-modulated radiotherapy (IMRT) and stereotactic body radiotherapy (SBRT), can effectively treat prostate cancer by delivering higher doses of radiation in fewer sessions, potentially improving outcomes without increasing side effects. ^{1 2 3 4 5}

Is radiation therapy for prostate cancer safe?

Research shows that hypofractionated radiation therapy (a type of radiation treatment given in larger doses over fewer sessions) for prostate cancer is generally safe, though some studies note potential acute side effects like genitourinary (urinary system) and gastrointestinal (digestive system) issues. ^{1 6 7 8 9}

How is hypofractionated radiation therapy different from other treatments for prostate cancer?

Hypofractionated radiation therapy for prostate cancer is unique because it uses higher doses of radiation in fewer sessions compared to traditional methods, potentially reducing treatment time while maintaining effectiveness. This approach, especially with techniques like stereotactic body radiotherapy (SBRT), can target the cancer more precisely, minimizing damage to surrounding healthy tissue and reducing side effects. ^{1 4 10 11 12}

Research Team

Quynh-Nhu Nguyen

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Acute toxicity of hypofractionated intensity-modulated radiotherapy for prostate cancer. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Dosimetric benefits of daily treatment plan adaptation for prostate cancer stereotactic body radiotherapy. [2022]

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

Four-Year Outcomes From a Prospective Phase II Clinical Trial of Moderately Hypofractionated Proton Therapy for Localized Prostate Cancer. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

A phase II study of hypofractionated proton therapy for prostate cancer. [2022]

6. United States 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. [2022]

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

Radiation Therapy for Prostate Cancer Using HYpofractionation Directed by UltraSound (RAPHYDUS): A Brazilian Public Health Care System Study. [2022]

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

Acute Toxicity Profiles of Hypofractionated Adjuvant and Salvage Radiation Therapy After Radical Prostatectomy: Results of a Prospective Study. [2019]

9. Italy 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. [2018]

10. France pubmed.ncbi.nlm.nih.gov

[Moderate or extreme hypofractionation and localized prostate cancer: The times are changing]. [2019]

11. Croatia pubmed.ncbi.nlm.nih.gov

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

12. England pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic body radiation therapy as monotherapy for intermediate-risk prostate cancer. [2021]