Types of Radiation Therapy for Prostate Cancer

Recruiting at 271 trial locations

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: NRG Oncology

Must not be taking: Androgen deprivation, Neoadjuvant chemotherapy

Disqualifiers: Prior malignancy, Severe comorbidity, 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: 6

Duration: 5-7 weeks

296 Participants Needed

Trial Summary

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

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on androgen deprivation therapy, there are specific conditions regarding its use before and after prostatectomy.

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

Research shows that higher doses of radiation are more effective for prostate cancer, and hypofractionated radiotherapy (using larger doses over fewer sessions) is as effective as standard treatment. Stereotactic body radiotherapy (SBRT) is a valuable option for certain patients, and modern techniques have improved cure rates and reduced side effects. ^{1 2 3 4 5}

Is radiation therapy for prostate cancer generally safe for humans?

Radiation therapy for prostate cancer, including hypofractionated radiation therapy (HFRT), is generally considered safe, though it may cause some short-term side effects like gastrointestinal issues. ^{1 2 6 7 8}

How does this radiation therapy treatment for prostate cancer differ from other treatments?

This treatment uses hypofractionated radiotherapy, which involves delivering larger doses of radiation in fewer sessions, making it more convenient and potentially more effective than traditional methods. It also includes advanced techniques like stereotactic body radiotherapy (SBRT) that precisely target the prostate, minimizing damage to surrounding tissues. ^{1 5 9 10 11}

What is the purpose of this trial?

This randomized phase III trial studies how well hypofractionated radiation therapy works compared to conventional radiation therapy after surgery in treating patients with prostate cancer. 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. Conventional radiation therapy uses high energy x-rays, gamma rays, neutrons, protons, or other sources to kill tumor cells and shrink tumors. It is not yet known whether giving hypofractionated radiation therapy or conventional radiation therapy after surgery may work better in treating patients with prostate cancer.

Research Team

Mark K Buyyounouski

Principal Investigator

NRG Oncology

Eligibility Criteria

Men who've had prostate surgery for adenocarcinoma, with certain pathology results (pT2 or pT3), and no evidence of metastasis. They must have a PSA level < 2.0 ng/mL post-surgery, good performance status, and be able to complete questionnaires in English or French. Excluded are those with prior long-term hormone therapy, other recent cancers except non-melanoma skin cancer, severe health issues like heart failure or uncontrolled infections.

Inclusion Criteria

I had surgery to remove my prostate cancer.

One of the following pathologic N-classifications: pN0, pNX

Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire

Exclusion Criteria

Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months, Transmural myocardial infarction within the last 6 months, Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 1 registration, Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of step 1 registration, Severe hepatic disease, defined as a diagnosis of Child-Pugh class B or C hepatic disease, Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol, End-stage renal disease (ie, on dialysis or dialysis has been recommended), Prior allergic reaction to the study drugs involved in this protocol, History of inflammatory bowel disease, prior bowel surgeries (or colostomy) for any reason, or prior partial/radical cystectomy for any reason

I have been on hormone therapy for prostate cancer for more than 6 months before surgery.

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 or hypofractionated radiation therapy after surgery

5-7 weeks

Daily visits for radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Every 6 months for 2 years, then yearly

Treatment Details

Interventions

• Hypofractionated Radiation Therapy
• Radiation Therapy

Trial Overview The trial is comparing two types of radiation therapy after prostate surgery: hypofractionated (higher doses over a shorter period) versus conventional (standard doses over a longer period). The goal is to see which method 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 for 25 fractions over 5 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive androgen deprivation therapy for up to 6 months as per doctor recommendation.

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

Patients undergo conventional radiation therapy for 37 fractions over 7 weeks in the absence of disease progression or unacceptable toxicity. Patients may also receive androgen deprivation therapy for up to 6 months as per doctor recommendation.

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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 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]

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 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]

In a clinical trial involving 201 patients with prostate cancer, the use of a hyaluronic acid rectal spacer significantly improved rectal dosimetry, with 98.5% of patients achieving a 25% or greater reduction in rectal volume receiving radiation, far exceeding the 70% target.

The spacer also reduced the incidence of acute grade 2 or higher gastrointestinal toxic effects, with only 2.9% of patients in the spacer group experiencing these effects compared to 13.8% in the control group, indicating a safer treatment option for hypofractionated radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyaluronic Acid Spacer for Hypofractionated Prostate Radiation Therapy: A Randomized Clinical Trial. Mariados, NF., Orio, PF., Schiffman, Z., et al.[2023]

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 radiotherapy for prostate cancer, which delivers larger doses in fewer sessions, has shown improved biochemical control of the disease, supported by multiple clinical trials.

Advanced radiation techniques like 3D conformal radiotherapy and intensity modulated radiation therapy enable higher doses to the prostate while protecting surrounding healthy tissues, making hypofractionation a safer and more effective option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of hypofractionated radiotherapy for prostate cancer. Spyropoulou, D., Kardamakis, D.[2021]

Stereotactic body radiation therapy (SBRT) is an effective and well-tolerated treatment option for localized prostate cancer, particularly for low and intermediate risk cases, with promising results for high-risk cancers as well.

The technique's sharp dose gradient allows for safe reirradiation in patients with local recurrence, highlighting its potential for treatment intensification in challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ultra-hypofractionated radiotherapy for the treatment of localized prostate cancer: Results, limits and prospects]. Graff, P., Crehange, G.[2021]

This ongoing phase II clinical study is investigating an ultra-hypofractionated radiotherapy scheme for low- or intermediate-risk prostate cancer patients, focusing on the feasibility and incidence of acute side effects.

The study aims to assess not only the immediate tolerability of the treatment but also its long-term effects on quality of life and oncological outcomes, with expectations of good tolerability and effectiveness based on previous research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and protocol of AIRC IG-13218, short-term radiotherapy for early prostate cancer with concomitant boost to the dominant lesion. Timon, G., Ciardo, D., Bazani, A., et al.[2018]

References

1. Croatia pubmed.ncbi.nlm.nih.gov

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

2. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

4. England pubmed.ncbi.nlm.nih.gov

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

5. Germany pubmed.ncbi.nlm.nih.gov

[External beam radiotherapy in the treatment of prostate cancer]. [2021]

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

Hyaluronic Acid Spacer for Hypofractionated Prostate Radiation Therapy: A Randomized Clinical Trial. [2023]

8. 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]

9. Egypt pubmed.ncbi.nlm.nih.gov

Review of hypofractionated radiotherapy for prostate cancer. [2021]

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

[Ultra-hypofractionated radiotherapy for the treatment of localized prostate cancer: Results, limits and prospects]. [2021]

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

Rationale and protocol of AIRC IG-13218, short-term radiotherapy for early prostate cancer with concomitant boost to the dominant lesion. [2018]