Prostate Cancer Clinical Trials

About Prostate Cancer trials

Prostate cancer trials are organized around two questions: where the cancer sits in the disease continuum (hormone-sensitive vs castration-resistant, localized vs metastatic), and which DNA repair or AR-pathway alterations the tumor carries. The biomarkers tested most often are the homologous recombination repair (HRR) genes: BRCA1, BRCA2, ATM, CHEK2, CDK12, and RAD51C. Together they define eligibility for PARP inhibitor trials, and roughly 25% of metastatic castration-resistant prostate cancer carries an HRR alteration. AR (androgen receptor) status is increasingly tested for AR mutations, AR amplification, and AR-V7 splice variant, all of which inform eligibility for next-generation AR antagonists or AR degraders. PTEN loss flags trials of AKT inhibitors and combination strategies. MMR deficiency is uncommon in prostate cancer (around 3-5%) but qualifies the rare patient for immunotherapy trials. HER2 (ERBB2) testing is emerging for trials targeting amplified or overexpressing tumors. TP53 and RB1 together signal aggressive-variant or neuroendocrine prostate cancer, which has its own trial set.

Prostate trial activity organizes around the disease state and the targeted mechanism. Newly diagnosed metastatic hormone-sensitive trials test combinations of androgen deprivation therapy (ADT) with second-generation AR antagonists, sometimes adding IO, PARP, or radioligand therapy. Castration-resistant trials split into pre-chemo, post-chemo, and post-androgen receptor signaling inhibitor (ARSI) groups. PARP inhibitor trials enroll patients with HRR alterations, increasingly in earlier lines including biochemical recurrence or high-risk localized settings. PSMA-targeted radioligand trials are a major active area following recent approvals of lutetium-based therapy, with trials testing earlier-line use, combinations with PARP or IO, and alternative isotopes. IO trials in prostate cancer are limited by historically low response rates but continue in MMR-deficient and select biomarker-defined subgroups. Aggressive-variant or neuroendocrine prostate cancer trials test platinum-based chemo and other novel mechanisms.

What prostate cancer trials gate on most often: the disease phase and prior treatments. Castration status is foundational: most trials require either a defined testosterone level (typically <50 ng/dL for castration-resistant trials) or specify hormone-sensitive disease. Prior AR signaling inhibitor (ARSI) exposure and which specific agent matter for many trials. Prior taxane chemotherapy is often a defining factor for line-specific trials, with the count and identity of prior taxanes typically specified. Prior PARP inhibitor and prior radioligand exposure are increasingly relevant criteria as those treatments enter earlier lines. HRR alteration status (BRCA1, BRCA2, ATM, CHEK2, CDK12, RAD51C) for PARP trials, with germline or somatic testing accepted by most trials. Visceral disease versus bone-only metastases matters for some trials. ECOG of 0 or 1 is standard.

Biomarkers tested in Prostate Cancer trials

These are the molecular markers most commonly required or evaluated in Prostate Cancer eligibility criteria. OncoMatch extracts them from each trial's protocol and matches them against your test results.