Adaptive Radiation Therapy for Prostate Cancer

(DE-CART Trial)

Overseen By Jianli Hu, MD, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Fox Chase Cancer Center

Must not be taking: Antineoplastic agents, Methotrexate

Disqualifiers: Prior pelvic radiation, Node-positive disease, Extraprostatic extension, Active infection, others

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

Compensation: Varies

Number of Visits: 1

Duration: 2-3 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating prostate cancer using adaptive stereotactic body radiation therapy (SBRT). Researchers aim to determine if this approach can safely target the prostate more precisely, reducing radiation to nearby organs and minimizing side effects, particularly those affecting urination. Participants will undergo five treatments over a few weeks and will have regular check-ups for several years to monitor side effects and overall health. This trial suits adults diagnosed with certain types of prostate cancer who have not received previous pelvic radiation therapy. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance future prostate cancer treatments.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on other investigational agents or certain cancer treatments like methotrexate. It's best to discuss your specific medications with the trial team.

What prior data suggests that adaptive SBRT is safe for treating prostate cancer?

Research has shown that adaptive stereotactic body radiation therapy (SBRT) is a promising and safe treatment for prostate cancer. One study found SBRT to be both safe and effective, with patients experiencing manageable side effects. This study followed patients for five years and reported positive results in controlling prostate cancer.

Another study noted that patients with a history of certain prostate surgeries experienced more urinary side effects, but overall, SBRT remained safe. Most patients did not experience severe side effects.

Additionally, a large study on patient-reported outcomes found that side effects were manageable even two years after treatment. This suggests that adaptive SBRT is generally well-tolerated over time.

Together, these studies indicate that adaptive SBRT for prostate cancer is a safe option, with side effects that most patients can handle. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Adaptive SBRT is unique because it personalizes radiation therapy for prostate cancer by adjusting the treatment in real-time to account for changes in tumor size, shape, or position. Traditional radiation therapy typically uses a fixed plan, but Adaptive SBRT can be fine-tuned, potentially increasing precision and effectiveness while minimizing damage to surrounding healthy tissue. Researchers are excited about this approach because it could lead to fewer side effects and better outcomes for patients, making it a promising advancement over current options.

What evidence suggests that adaptive SBRT is effective for treating prostate cancer?

Research has shown that stereotactic body radiation therapy (SBRT) is promising for prostate cancer. Studies have found that SBRT effectively controls cancer, with many patients remaining cancer-free for at least five years. In this trial, participants will receive adaptive SBRT, which can more accurately target the prostate and may help protect nearby organs from excessive radiation. However, some studies have reported an increase in urinary side effects for certain patients. Overall, SBRT is considered effective, especially for those with lower Gleason scores, which measure cancer aggressiveness. These findings suggest that adaptive SBRT could be a good option for treating prostate cancer. ^{1 2 5 6 7}

Who Is on the Research Team?

Mark A Hallman, MD, PhD

Principal Investigator

FCCC

Are You a Good Fit for This Trial?

This trial is for adult men with intermediate- or high-risk prostate cancer. Participants should be suitable for radiation therapy and willing to follow the treatment schedule and attend all follow-up appointments. Specific details on inclusion and exclusion criteria are not provided.

Inclusion Criteria

My prostate cancer is at an early but risky stage.

I am older than 18 years.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

Subjects must not be receiving any other investigational agents

My cancer has not spread to the lymph nodes.

My MRI shows no cancer spread beyond the prostate before starting hormone therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adaptive SBRT treatment every other day, for a total of 5 treatment sessions over 2 to 3 weeks

2-3 weeks

Initial Follow-up

Participants have a follow-up phone call about 6 weeks after treatment to check on side effects and overall wellbeing

6 weeks

1 visit (phone call)

Extended Follow-up

Participants visit the clinic for check-ups and tests at 90 days after treatment, then every 3 months for the first year, and every 6 months thereafter

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Adaptive SBRT

Trial Overview The trial tests adaptive SBRT, a precise radiation therapy aimed at treating prostate cancer while minimizing damage to surrounding organs. It involves five sessions of targeted radiation over 2-3 weeks, with long-term follow-up to assess safety and effectiveness.

How Is the Trial Designed?

Group I: Phase I Dose escalated adaptive stereotactic body radiation therapy (SBRT) with a SIB Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials

236

Recruited

39,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8557180/

Five-year outcomes of stereotactic body radiation therapy ... SBRT is a safe and effective treatment with an encouraging bPFS rate and tolerable toxicity for localized PCa patients. Patients with a Gleason score < 8 and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405630823001349

Stereotactic body radiation therapy for prostate cancer after ... All the five patients (17.9 %) with a previous history of TURP treated with SBRT presented a grade 3 GU toxicity compared to only one single patient in the VMAT ...

3. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-025-02653-4

Online adaptive stereotactic body radiotherapy for localized ... The PACE-B RCT demonstrated that SBRT results in excellent oncological outcomes with a 5-year biochemical and biochemical progression-free ...

4. cancer.gov cancer.gov/news-events/cancer-currents-blog/2024/prostate-cancer-sbrt-effective-safe

SBRT Proves Effective for Some Prostate Cancers - NCI Trial participants who were randomly assigned to receive SBRT had a higher risk of developing some urinary problems over the first 2 years after ...

5. advancesradonc.org advancesradonc.org/article/S2452-1094(24)00264-1/fulltext

First-in-Men Online Adaptive Robotic Stereotactic Body ... This paper focuses on the development, preclinical validation, and clinical testing of online adaptive robotic stereotactic body radiation therapy for this ...

6. advancesradonc.com advancesradonc.com/article/S2452-1094(24)00137-4/fulltext

Acute and Late Patient-Reported Toxicity Outcomes Our study is one the largest patient-reported outcomes study after prostate SMART. It shows acceptable levels of toxicity even up to 2 years after treatment.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07219303

Adaptive Radiation Therapy for Men With Intermediate- or ... The goal of this clinical trial is to evaluate if adaptive stereotactic body radiation therapy (SBRT) is a safe and effective way to treat ...