A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibitio… (NCT04194554) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer
United States102 participantsStarted 2020-11-06
Plain-language summary
The purpose of this study is to establish the maximum tolerable dose of niraparib when combined with prostate stereotactic body radiotherapy (SBRT), abiraterone, leuprolide, and prednisone (the phase 1 portion of the study) and determine 3-year biochemical PSA recurrence free-survival with this treatment approach (the phase 2 portion of the study).
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Pathologic biopsy proven adenocarcinoma of the prostate
✓. At least one of the following criteria:
✓. Age ≥ 18
✓. ECOG \< 1
✓. Adequate organ and marrow function as defined per protocol.
✓. Use of highly effective contraception (e.g. condoms) for the duration of treatment and a minimum of 120 days thereafter. Men must also agree not to donate sperm for the duration of the study participation, and for at least 120 days thereafter.
✓. International Prostate Symptoms Score (IPSS) ≤ 20
✓. Medically fit for treatment and agreeable to follow-up
Exclusion criteria
✕. Clinical or radiographic evidence of distant metastatic disease by CT/bone scan
✕. Clinical or radiographic evidence of high probability of clinical T4 disease
✕. Prostate gland size \>80 cc measured by ultrasound or MRI
✕. Prominent median lobe assessed by treating physician
✕. Lack of tissue from biopsy to be sent for correlative studies
✕
What they're measuring
1
Dose-limiting toxicities (Phase 1)
Timeframe: Up to 112 days after initial dose of niraparib
2
Proportion of patients experiencing biochemical failure
Timeframe: Up to 3 years after first dose of niraparib
. Any prior treatment for prostate cancer (incudes history of TURP within 5 years of enrollment, chemotherapy, radiation therapy, or anti-androgen therapy)
✕. Prohibited within 30 days prior to administration to study treatment: spironolactone and other investigational drug therapies.
✕. Prohibited 3 months before participant registration and during administration of study treatment: non-steroidal anti-androgens (e.g., bicalutamide, flutamide, nilutamide), steroidal antiandrogens (megestrol acetate, cyproterone acetate), oral ketoconazole, chemotherapy, immunotherapy, estrogens, radiopharmaceuticals.