Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostate… (NCT03047135) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis
United States51 participantsStarted 2017-03-01
Plain-language summary
Olaparib has demonstrated preliminary efficacy in metastatic castration-resistant prostate cancer. In a trial of 49 evaluable patients treated with olaparib, 11 / 49 experienced a PSA response, and every patient with a radiographic response also had a PSA5 response.
Ten of 11 responders had mutations in DNA repair genes. While PARP inhibition is showing promise in these initial studies, reserving its use for end-stage patients may not be the optimal timing for olaparib therapy in some patients. In addition, PARP enzymes function in roles beyond DNA repair, and specifically for prostate cancer are involved transcriptional regulation of the androgen receptor. PARP inhibition has not been tested in earlier disease states for prostate cancer.
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
✓. Histologic diagnosis of adenocarcinoma of the prostate
✓. Prior local therapy with prostatectomy required, with available tissue from prostatectomy specimen to send for genomic and transcriptomic testing.
✓. Prior salvage or adjuvant radiation therapy is allowed but not mandated. Radiation therapy must have been completed for at least 6 months.
✓. Absolute PSA ≥1 ng/ml. Prior undetectable PSA post-prostatectomy is not required.
✓. PSADT ≤6 months, based upon ≥3 consecutive measurements collected in the past 12 months, at least 4 weeks apart
✓. No radiographic evidence of metastatic disease by CT scan and bone scan, performed within the prior 4 weeks.
✓. Serum testosterone ≥ 150 ng/dl
✓. Participants must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
Exclusion criteria
✕
What they're measuring
1
PSA50 Response Rate to Olaparib for Patients With High-risk Biochemically-recurrent Prostate Cancer
Timeframe: 6 years 2 months
Trial details
NCT IDNCT03047135
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
. Prior ADT in the past 6 months. Prior ADT in context of neoadjuvant/adjuvant primary; prior ADT for biochemical recurrence is allowed, as long as no ADT has been administered in past 6 months and testosterone has recovered (\>150 ng/dl). The total duration of prior ADT should not exceed 24 months.
✕. Prior oral anti-androgen (e.g. bicalutamide, nilutamide, enzalutamide, apalutamide), or androgen synthesis inhibitor (e.g. abiraterone, orteronel) in the past 6 months. 5-alpha reductase inhibitor therapy (e.g. finasteride, dutasteride) is allowed, as long as subject has been stable on medication for past 6 months.
✕. Prior treatment with intravenous chemotherapy.
✕. Involvement in the planning and/or conduct of the study
✕. Participation in another clinical study with an investigational product during the last 1 month.
✕. Any previous treatment with PARP inhibitor, including olaparib
✕. Resting ECG with QTc \> 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome
✕. Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.