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 range18 Years
SexMALE
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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…
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