Radiotherapy for Prostate Cancer

(COMBINE Trial)

Overseen By Pavel Noa Hechevarria

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Previous pelvic radiotherapy, others

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

Compensation: Varies

Number of Visits: 1

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how standard radiation treatments for prostate cancer, such as postoperative and primary radiotherapy, might alter MRI and PET scan results and how these changes could predict treatment responses. It also examines the number of circulating tumor cells (CTCs) in the blood before and after radiation to understand their relationship with imaging changes and gene expression in cancer tissue. Men with confirmed prostate cancer, regardless of cancer stage or Gleason Score, who have not previously received pelvic radiotherapy, may be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in prostate cancer care.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on androgen deprivation therapy (ADT), it must be declared and categorized as none, short-term, long-term, or extended before you enroll.

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

Research has shown that postoperative radiotherapy is generally well-tolerated and can safely reduce the risk of cancer recurrence in some cases. For instance, one study found that 91.2% of patients did not experience local cancer recurrence within two years after receiving this treatment following surgery. Additionally, trials indicate that this type of radiotherapy usually causes only minor side effects.

Regarding primary radiotherapy, evidence suggests it is also safe, though long-term side effects can occur. These side effects might appear after treatment concludes. While serious issues are rare, they can occur, often due to errors during treatment. However, the likelihood of such errors is low—about 1,500 mild to moderate side effects per 1,000,000 treatments.

Overall, both types of radiotherapy are widely used and considered effective, with safety measures in place to minimize risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Collection and Measurement of Biomarkers in Prostate Cancer Radiotherapy Patients trial because it aims to uncover new insights into how prostate cancer patients respond to radiotherapy. Unlike standard treatments that primarily focus on eradicating cancer cells, this trial seeks to identify specific biomarkers—biological indicators that can predict how well a patient will respond to radiotherapy. By understanding these biomarkers, doctors could tailor treatments more precisely, potentially improving outcomes and reducing side effects. This approach represents a significant shift towards personalized medicine, where treatments are customized based on an individual's unique biological makeup.

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

Research has shown that primary radiotherapy, one of the treatments in this trial, can effectively treat prostate cancer. Studies have found it can reduce the risk of death from this cancer by 46%. Another study found that low-dose radiation therapy benefits about 1 in 5 patients, providing lasting effects for some.

Postoperative radiotherapy, another treatment option in this trial, is typically administered after surgery to enhance outcomes. Some research suggests it can increase overall survival rates, particularly for certain cancer types. Although specific data for prostate cancer is limited, this treatment has demonstrated benefits in other cancers, suggesting it might offer similar advantages. ^{6 7 8 9 10}

Who Is on the Research Team?

Alan Pollack, MD, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

Inclusion Criteria

Pathologic confirmation of prostate cancer.

Any T-stage.

By imaging or clinical criteria, any patient with disease staging of N0/N1 and M0/M1.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive standard radiation treatment to the prostate or pelvis after prostatectomy

8 weeks

Regular visits for radiation sessions

Post-Treatment Monitoring

Quantitative imaging parameters and circulating tumor cell (CTC) changes are monitored

3 months

1 visit (in-person) at 3 months post-RT

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-2.5 years

Periodic visits for imaging and biopsy assessments

What Are the Treatments Tested in This Trial?

Interventions

• Postoperative Radiotherapy
• Primary Radiotherapy

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Bankhead-Coley Florida Biomedical Research Program

Collaborator

Trials

3

Recruited

280+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/7425243/

Evaluation of the effectiveness of postoperative radiation ... Our data reveal a recurrence rate of 32.7 percent in advanced, stage III and IV, squamous cell carcinomas in the head and neck treated by surgery and ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2212555824001066

Outcomes of postoperative radiotherapy combined with or ... The findings indicated that the combination of radiotherapy and chemotherapy resulted in significantly greater progression-free survival (PFS, p = 0.04) and OS ...

3. nature.com nature.com/articles/s41598-023-29888-z

The optimization of postoperative radiotherapy in de novo ... These real-world data show that postoperative radiotherapy might improve overall survival for de novo Stage IV breast cancer with bone or lung metastasis, ...

4. tcr.amegroups.org tcr.amegroups.org/article/view/93509/html

Comparison of postoperative radiotherapy and definitive ... The study revealed 3- and 5-year overall survival (OS) rates of 78% and 79.7%, respectively, along with locoregional recurrence-free survival ( ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2025/07250/postoperative_radiotherapy_enhances_survival_in.54.aspx

Postoperative radiotherapy enhances survival in NSCLC... While PORT does not universally improve survival outcomes for all patients with pN2 NSCLC, it improves survival for those with a moderate number of PLNs.

6. astro.org astro.org/news-and-publications/news-and-media-center/news-releases/2025/radiation-therapy-after-surgery-safely-reduces-pelvic-relapse-risk-from-locally-advanced-mibc

Radiation therapy after surgery safely reduces pelvic ... Two-year locoregional recurrence-free survival, the study's primary endpoint, was 91.2% with radiation therapy versus 76.4% without (p=0.004). “ ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12554120/

Long-term outcomes of postoperative radiotherapy for patients ... In the PP analysis, the long-term results showed no significant difference in DFS (3-year: 43.4%, 95% CI, 35.2%–51.6%; vs. 34.1%, 95% CI, 27%–41.2%; 5-year: ...

8. cancernetwork.com cancernetwork.com/view/exclusive-radiation-therapy-improves-qol-and-safety-outcomes-in-breast-cancer

Exclusive Radiation Therapy Improves QOL and Safety ... When compared with endocrine therapy, radiation therapy improved quality of life and adverse effects data, the phase 3 EUROPA study showed.

9. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2835449

Therapy, Safety, and Logistics of Preoperative vs ... Overall, these trials demonstrated that postoperative SRS is associated with high rates of local control with minimum adverse effects, while ...

10. urotoday.com urotoday.com/conference-highlights/astro-2025/astro-2025-prostate-cancer/163439-astro-2025-safety-and-efficacy-of-postoperative-ablative-radiotherapy-popart-for-post-prostatectomy-biochemical-recurrence.html

ASTRO 2025: Safety and Efficacy of POstoPerative ... Dr. Stefano Arcangeli presented the results of POPART, a study evaluating the safety and efficacy of post-operative ablative radiotherapy in the ...