Hypofractionated Radiotherapy for Prostate Cancer

Overseen By Deborah E Citrin, M.D.

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: Protease inhibitors

Disqualifiers: Metastases, Radiation history, Bowel disease, others

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

Compensation: Varies

Number of Visits: 7

Duration: 2-4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radiation schedule for prostate cancer that returns after surgery. Instead of the usual 6 or 7 weeks of daily treatments, researchers aim to determine if shorter treatment periods can be equally effective with fewer side effects. The study includes two groups: one receives a radiation boost directly to the tumor seen on scans (dose to prostate bed with integrated boost), and the other receives standard radiation to the entire prostate area (dose to prostate bed irradiation only). Individuals who have undergone prostate cancer surgery and require radiation might be suitable candidates, especially if scans or blood tests detect their cancer. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new approach.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are taking investigational drugs or radiosensitizing drugs (medications that make cancer cells more sensitive to radiation).

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

Research has shown that hypofractionated radiotherapy, a shorter radiation treatment, can be safe for prostate cancer patients. Studies on treatments like "dose to prostate bed irradiation only" have reported few side effects, with patients experiencing no increase in urinary or bowel function problems. Long-term data supports that this shorter treatment is as effective and safe as the longer, traditional one.

For "dose to prostate bed with integrated boost," evidence indicates that the treatment is generally well-tolerated. Reports show that both short-term and long-term side effects were manageable, suggesting that the integrated boost does not significantly increase side effects.

Overall, both treatment methods in past studies have demonstrated low risks of severe side effects, making them potentially safe options for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about hypofractionated radiotherapy for prostate cancer because it could significantly shorten treatment times compared to traditional radiation therapy. Typically, prostate cancer treatment involves multiple weeks of daily radiation sessions, but hypofractionated radiotherapy delivers higher doses in fewer sessions, potentially reducing the treatment duration. Additionally, the integrated boost technique in one arm of the study targets the prostate bed more intensely, which might improve precision and effectiveness while minimizing exposure to surrounding healthy tissues. This approach could offer a more convenient and potentially more effective option for patients, making it an appealing advancement in prostate cancer treatment.

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

This trial will compare two approaches to hypofractionated radiotherapy for prostate cancer. One arm will deliver a dose to the prostate bed with an integrated boost, while the other will involve irradiation of the prostate bed only. Studies have shown that hypofractionated radiotherapy, a shorter and more intense radiation schedule, can effectively treat prostate cancer. Research indicates that this shorter course of radiation can be as effective and safe as the longer, traditional schedule. For treatment focused only on the prostate bed, studies have found no increase in side effects like urinary or stomach issues. When the prostate bed receives an added boost, research shows it is effective with few side effects, helping to control the cancer. Early findings suggest this approach can protect healthy cells while targeting the cancer more effectively. Overall, this type of treatment has shown promising results in controlling and reducing the recurrence of prostate cancer. ^{2 3 6 7 8}

Who Is on the Research Team?

Deborah Citrin, MD

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

Men over 18 who've had their prostate removed and need radiation can join. They must use birth control, have a stable health status (ECOG ≤1), and no history of severe immune deficiency or opportunistic infections if HIV+. No current participation in other trials, prior pelvic radiation, inflammatory bowel disease, lupus, scleroderma, genetic hypersensitivity to radiation or metastases outside the pelvis are allowed.

Inclusion Criteria

Ability of subject to understand and the willingness to sign a written informed consent document

I am mostly able to care for myself and carry out daily activities.

I am HIV positive with a stable condition, meeting specific health criteria.

Exclusion Criteria

Subjects with any coexisting medical or psychiatric condition which, in the opinion of the Investigator likely to interfere with study procedures and/or results

I have had radiation in the same area where my prostate is.

My prostate cancer has spread outside the pelvis, but not beyond the prostate bed region.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive hypofractionated radiation treatment to the prostate bed, with an integrated boost to visible tumors, Monday through Friday for 2, 3, or 4 weeks

2-4 weeks

Daily visits (in-person, Monday through Friday)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits including examinations and blood tests

2 years

6 visits over 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Dose to prostate bed irradiation only
• Dose to prostate bed with integrated boost

Trial Overview Researchers are testing shorter schedules of post-prostatectomy radiotherapy to see if they're as effective with fewer side effects. Some patients will receive standard doses while others get an increased dose focused on tumor areas identified by scans.

How Is the Trial Designed?

Group I: Arm 2/Prostate Bed Irradiation Only Experimental Treatment 6 Interventions

Prostate bed irradiation only.

Group II: Arm 1/Prostate Bed with Integrated Boost Experimental Treatment 6 Interventions

Prostate bed with integrated boost.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12077468/

Hypofractionated radiotherapy for localized prostate cancer This trial aims to investigate the safety outcomes of HFRT in 15 fractions for treating patients with localized PCa.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1558767324000739

10-yr Results of Moderately Hypofractionated ... Our study provides long term data that a shortened course of postoperative RT is as safe and effective as a long course of conventionally fractionated RT.

3. nrgoncology.org nrgoncology.org/Home/News/Post/hypofractionated-post-operative-prostate-bed-radiotherapy-does-not-increase-patient-reported-toxicity-for-men-with-prostate-cancer

Hypofractionated Post-Operative Prostate Bed ... Treatment with HYPORT yielded no increase in patient-reported genitourinary (GU) or gastrointestinal (GI) toxicity for trial participants.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11756135/

Hypofractionated image-guided radiotherapy with 70 Gy in ... Hypofractionated image-guided radiotherapy, delivering 70 Gy at 2.5 Gy per fraction, is both effective and safe for Taiwanese patients with prostate cancer ...

5. mdpi.com mdpi.com/2673-592X/4/4/29

Exploring Hypofractionated Radiotherapy Efficacy in ... The findings indicate that hypofractionation may help preserve non-cancerous cells while potentially improving outcomes for aggressive prostate cancer types.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39143977/

Moderate hypofractionated radiotherapy to the prostate ... Hypofractionated radiotherapy in postoperative prostate cancer appears to be safe with low reports of relevant acute or late toxicity.

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

Treatment outcomes with hypofractionated high-dose ... The prostate cancer-specific survival at 5 years was 98%, Fig. 1b. In general, the progression-free survival rate at 5 years was 86.6%, and 94%, 89% and 74% (p ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S240563082300037X

Review Article Acute and late toxicity patterns of moderate ... Moderate hypofractionated (HF) radiotherapy is becoming the new standard in radiotherapy for prostate cancer patients. It is established as safe, but it might ...