Using targeted radiation therapy for prostate cancer with limited metastases
Androgen Deprivation Therapy (ADT) Versus Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Prostate Cancer: A Prospective Randomized Control Clinical Trial
This study is testing whether a type of targeted radiation therapy can help men with a few spots of prostate cancer live longer without needing hormone therapy right away.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Changhai Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT04599686 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and feasibility of stereotactic body radiotherapy (SBRT) without androgen deprivation therapy (ADT) in men with oligometastatic prostate cancer. Participants will be randomized to receive either ADT or SBRT within six weeks of their diagnosis, with the goal of determining how long SBRT can prolong biochemical progression-free survival. The study will utilize Ga-68 PSMA PET/CT imaging to accurately diagnose metastases and assess treatment outcomes. By focusing on patients with a limited number of metastases, the study seeks to delay the need for hormonal therapy, which can have significant side effects.
Who should consider this trial
Good fit: Ideal candidates are men aged 80 years or younger with histologically confirmed prostate adenocarcinoma and one to five oligometastatic lesions.
Not a fit: Patients with previous treatments for oligometastases or those with unstable lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option that delays the need for hormonal therapy in men with oligometastatic prostate cancer.
How similar studies have performed: Other studies have shown promising results with SBRT in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 80 years old * Histologically confirmed adenocarcinoma of the prostate * Prostate cancer treated with curative intent (radical prostatectomy, primary radiotherapy, or a combination of both) * Ga-68 prostate-specific membrane antigen (PSMA) PET/CT evidence of one to three metastases (bone or lymph node) within 6 weeks of enrolment, if the position of oligometastases is judged by the doctor to be in the same radiotherapy area, the number of metastases can be appropriately increased to 5 * Without ADT treatment * PSA\< 50ng/ml * ECOG performance status 0-2 * Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures Exclusion Criteria: * Any previous or ongoing treatment of oligometastases including radiotherapy, ADT, chemotherapy, focal treatment, etc. * Unstable lesions with spinal or long bone metastases * A tumor located at less than 3 mm from the urethra or rectum when measured at the MRI * 4 metastases, or if the metastases are in the same radiotherapy area, ≥6 metastases * Histologically confirmed neuroendocrine tumor or small cell carcinoma of the prostate * Severe or active co-morbidity likely to impact on the advisability of SBRT like severe liver or kidney dysfunction, etc. * Patients with other malignancies, or acute or other severe infections, with ulcerative colitis, inflammatory bowel disease, etc. * Patients who have participated in other clinical trials for less than three months * Unsuitable to participate in this clinical trial judged by the investigator
Where this trial is running
Shanghai, Shanghai
- Changhai hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Huojun Zhang, PhD
- Email: chyyzhj@163.com
- Phone: 021-31162222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.