New radiation therapy approach for prostate cancer

A Phase I Dose Escalation Study of Hypofractionated Accelerated Pelvic Nodal Radiotherapy Delivered With A Simultaneously Integrated Prostate Boost For Patients With Localized, Intermediate- And High-Risk Prostate Cancer (GCC 2048)

This study is testing a new type of radiation therapy for men with high-risk prostate cancer to see if it can be safer and more effective than the usual treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: University of Maryland, Baltimore (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT04486755 on ClinicalTrials.gov

What this trial studies

This phase I trial investigates the safety of delivering three shorter schedules of hypofractionated pelvic nodal radiotherapy in combination with a simultaneous integrated boost to the prostate. The study aims to increase the biological equivalent dose to prostate cancer while minimizing toxicity to normal tissues. It targets patients with unfavorable intermediate-risk and high-risk prostate cancer, who typically require multimodal treatment. The trial will assess the effectiveness of this innovative radiation therapy approach compared to standard treatments.

Who should consider this trial

Good fit: Ideal candidates are adult patients aged 18 and older with pathologically confirmed intermediate to high-risk prostate adenocarcinoma who require pelvic and prostatic irradiation.

Not a fit: Patients with evidence of bone metastases or those with significant lymph node involvement beyond the specified criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with high-risk prostate cancer by delivering more effective radiation therapy with reduced side effects.

How similar studies have performed: Previous studies on hypofractionated radiation therapy have shown promising results, indicating potential benefits in similar patient populations.

Eligibility criteria

Inclusion Criteria:

1. Patient age is ≥ 18 years
2. Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration.
3. Patient's with intermediate to high risk prostate cancer and must be recommended to undergo pelvic as well as prostatic irradiation.
4. History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration.
5. Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MR), (but not by nodal sampling, or dissection) within 120 days prior to registration.

   • Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm.
6. No evidence of bone metastases (M0) on bone scan within 120 days prior to registration.

   • Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis.
7. Baseline serum PSA value performed within 12 weeks (90 days) prior to registration.
8. ECOG Performance Status 0-1
9. Patient must be able to provide study specific informed consent prior to study entry.

Exclusion Criteria:

1. Evidence of distant metastases
2. Regional lymph node involvement
3. Previous radical surgery (prostatectomy), cryosurgery, or HIFU (High-intensity focused ultrasound) for prostate cancer
4. Previous pelvic irradiation or prostate brachytherapy
5. Planned prostate brachytherapy boost
6. Previous or concurrent cytotoxic chemotherapy for prostate cancer
7. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
8. Patients are excluded if they have a history of autoimmune disease that, in the opinion of the treating physician would be a contraindication to pelvic radiation (e.g., active systemic lupus, progressive scleroderma)
9. Patients receiving full-dose anticoagulation or clopidogrel

   • Patients taking 81 mg Aspirin po daily may are still eligible for the study
10. Patients with a history of prior small bowel ulceration

Where this trial is running

Baltimore, Maryland

• Maryland Proton Treatment Center — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Study coordinator: Mark Mishra, MD

Conditions Prostate Cancer; Prostate Adenocarcinoma; Prostate; Hypofractionated Radiation Therapy; Radiotherapy; Proton Therapy