Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer (NCT03796767) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Salvage Oligometastasectomy and Radiation Therapy in Recurrent Prostate Cancer
United States20 participantsStarted 2019-09-09
Plain-language summary
This phase II trial studies how well surgery and radiation therapy work in treating patients with prostate cancer that has come back or spread to other parts of the body. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Surgical procedures, such as oligometastasectomy, may remove tumor cells that have spread to other parts of the body. Surgery and radiation therapy may work better in treating patients with prostate cancer that has come back or spread to other parts of the body.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically proven adenocarcinoma of the prostate.
* Recurrent prostate carcinoma after definitive therapy for primary disease defined as:
* Post-prostatectomy (with/without adjuvant radiotherapy): Patients must have a detectable or rising PSA level that is \> 0.05 ng/mL, with a second confirmatory level of \> 0.05 ng/mL after a minimum of 1 week.
* Post radiotherapy/ablation (without radical prostatectomy): PSA rise \>= 2ng/mL over nadir.
* Subjects treated with prior definitive radiotherapy for prostate cancer who have positive molecular imaging (e.g., fluciclovine PET/CT scan or other per PI discretion) suggesting recurrent intraprostatic disease must undergo transrectal ultrasound (TRUS) biopsy less than or equal to one year before study enrollment:
* If the TRUS biopsy is negative, no additional treatment is required to the prostate in addition to that of scan positive sites.
* If the TRUS biopsy is positive, subject must undergo salvage prostatectomy or salvage radiotherapy to the primary site concurrently with the study treatment per the treatment protocol algorithm.
* NOTE: Biopsy is not required for prostate fossa recurrences after radical prostatectomy.
* Oligometastatic disease defined as 10 or fewer metastatic lesions to lymph nodes and/or bones only.
* For patients with oligometastatic disease involving lymph nodes, metastasis is confined to the pelvic or para-aortic (below IMA) regions on molecular imaging (e.g., fluciclovin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prostate-specific Antigen (PSA) ≥ 50% 6 Months After Completion of All Treatment
Timeframe: 6 months after completion of 5-21 weeks of treatment