AstraZeneca opens third Phase 3 saruparib trial in prostate cancer
EvoPAR-PR05 tests saruparib after docetaxel or Lu-177-PSMA therapy, extending AstraZeneca's PARP inhibitor into a maintenance setting no competitor currently occupies.
Executive Summary
- AstraZeneca has registered a Phase 3 trial testing whether adding its oral PARP inhibitor saruparib to standard hormone therapy extends disease control in men whose metastatic prostate cancer has not progressed after taxane chemotherapy or radioligand therapy.
- The trial targets a treatment sequence, maintenance therapy after docetaxel or Lu-177-PSMA, that sits outside where AstraZeneca's other two Phase 3 saruparib prostate cancer trials are testing the drug, pointing to a strategy of covering multiple points in the treatment pathway rather than betting on one line of therapy.
- No other PARP inhibitor program is running a registrational trial in this specific post-taxane or post-radioligand maintenance population, though other PARP inhibitors including olaparib, niraparib and talazoparib are already established in different prostate cancer settings.
- The trial has not yet started recruiting, and its primary completion date lands in mid-2031, making this an early marker of AstraZeneca's development roadmap rather than a near-term efficacy catalyst.
The new trial
The trial, registered as NCT07711002 and named EvoPAR-PR05, will randomize 1,330 patients to saruparib plus physician's choice of an androgen receptor pathway inhibitor (ARPI, a hormone-blocking drug class) or ARPI alone. Enrollment applies to men whose metastatic hormone-sensitive prostate cancer has not progressed after a course of docetaxel or Lu-177-PSMA therapy, and who still show a detectable PSA level of at least 0.2 ng/mL, a biomarker of residual disease. The primary endpoint is radiographic progression-free survival, assessed by imaging criteria over a monitoring window of roughly 56 months. The trial has not yet started recruiting and lists a primary completion date of June 17, 2031. NCT07711002Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05)NCT07711002
Design and eligibility
Enrollment requires confirmed metastatic disease before prior treatment, ongoing androgen deprivation therapy, resolution of chemotherapy-related toxicities to a low grade, and testing for HRR gene mutation status, HRD (homologous recombination deficiency) and PTEN status, biomarkers relevant to PARP inhibitor activity. Patients who previously received a PARP inhibitor or platinum chemotherapy are excluded. The trial is randomized, quadruple-masked (blinding patients, caregivers, investigators and outcome assessors), and runs across two arms in a design AstraZeneca has used across its saruparib prostate cancer program. NCT07711002Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05)NCT07711002
A three-trial sequencing strategy
This is AstraZeneca's third active Phase 3 trial of saruparib in prostate cancer. One trial, NCT06952803, tests saruparib against placebo added to radiotherapy and hormone therapy in high-risk BRCA-mutated prostate cancer, with a primary completion date in March 2033. Another, NCT06120491, compares saruparib to placebo in metastatic castration-sensitive prostate cancer patients receiving physician's choice hormone therapy, completing around September 2027. EvoPAR-PR05 occupies a distinct slot: patients who have already received docetaxel or radioligand therapy and have not progressed, a maintenance-oriented population none of AstraZeneca's other prostate cancer trials specifically targets. NCT07711002Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05)NCT07711002
The competitive field
PARP inhibitors are established in prostate cancer through drugs including olaparib, niraparib and talazoparib, each tested in earlier or later disease settings, but none is running a registrational trial in this specific post-taxane, post-radioligand maintenance population. AstraZeneca's own olaparib and saruparib programs otherwise dominate the target-level trial count for PARP1 in prostate cancer, with AstraZeneca listed as the sponsor on the largest share of active PARP1 trials in the indication. Historical trials pairing PARP1 inhibition with a prostate adenocarcinoma diagnosis specifically have ended in termination twice, though neither of those two trials involved saruparib, and AstraZeneca's own completion rate across its broader PARP program stands near 96% across 52 trials. NCT07711002Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05)NCT07711002
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