NCT02016248 SBRT Boost for Unfavorable Prostate Cancer'
| NCT ID | NCT02016248 |
| Status | Recruiting |
| Phase | — |
| Sponsor | MemorialCare Health System |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2012-06 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2012-06 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to find out whether giving a short course of focused radiation called an SBRT "boost" is a safe and effective way to treat prostate cancer. This boost delivers a high dose of radiation to the prostate in a non-invasive way, similar to what is done with high dose rate (HDR) brachytherapy but without using needles. The study looks at how well this treatment controls the cancer, what side effects it may cause, and how it affects patients' quality of life over time.
Eligibility Criteria
Inclusion * Histologically proven prostate adenocarcinoma * Biopsy within 12 months of date of registration required except for patients who already meet criteria for enrollment in the high risk arm of the protocol. For these patients, repeat biopsy will be at the discretion of the treating physician. In general, repeat biopsy is recommended for these patients, but is not required if it will not affect the treating physician's management decisions in regards to the care of the patient. * Clinical Stage I-IV, MX-M0 (AJCC VERSION 9) * M-stage determined by physical exam, CT, MRI, bone scan, PSMA PET/CT, or biopsy. * Prostate volume: ≤ 100 cc (recommended not required) * Determined using: volume = π/6 x length x height x width * Measurement from CT, MRI or ultrasound ≤ 90 days prior to registration. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * No prior prostatectomy or cryotherapy of the prostate * No prior radiotherapy to the prostate or lower pelvis * No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion. * Completion of patient questionnaires in section 3.7. * Consent signed Exclusion * No prior prostatectomy or cryotherapy of the prostate * No prior radiotherapy to the prostate or lower pelvis * No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
Contact & Investigator
Asif Harsolia, MD
PRINCIPAL INVESTIGATOR
MemorialCare
Frequently Asked Questions
Who can join the NCT02016248 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02016248 currently recruiting?
Yes, NCT02016248 is actively recruiting participants. Contact the research team at stolentino2@memorialcare.org for enrollment information.
Where is the NCT02016248 trial being conducted?
This trial is being conducted at Fountain Valley, United States, Laguna Hills, United States, Long Beach, United States.
Who is sponsoring the NCT02016248 clinical trial?
NCT02016248 is sponsored by MemorialCare Health System. The principal investigator is Asif Harsolia, MD at MemorialCare. The trial plans to enroll 150 participants.
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