Prostate cancer tests

Carboplatin & Paclitaxel (CP)

CP: Carboplatin & Paclitaxel

Regimen

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Forde et al. 2022 (CheckMate 816)	2017-2019	Phase 3 (C)	1a. CP & Nivolumab 1b. CVb & Nivolumab 1c. DC & Nivolumab	Inferior EFS

Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details. This study was conducted in the United States. The reason for the study was that an unanswered question at the time was whether adding an immune checkpoint inhibitor would improve outcomes.

Biomarker eligibility criteria

• CheckMate 816: No sensitizing EGFR or ALK mutations

Chemotherapy

• Carboplatin (Paraplatin) AUC 5 or 6 IV once on day 1
• Paclitaxel (Taxol) 175 or 200 mg/m² IV once on day 1

21-day cycle for 3 cycles

Subsequent treatment

• Complete resection

References

1. CheckMate 816: Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. Epub 2022 Apr 11. link to original article contains dosing details in manuscript PubMed NCT02998528

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PSA

• Prostate specific antigen. Increased PSA correlates with risk of prostate cancer and risk of aggressive prostate cancer, but does not mean that somebody has prostate cancer.
• May be transiently elevated due to:
  • Enlarged prostate, benign prostatic hypertrophy (BPH)
  • Infection (prostatitis)
  • Ejaculation/sexual activity
  • Digital rectal exam (DRE), prostate exam
  • Biopsies or other instrumentation
• Different upper limits of normal values depending on age:

Normal limits of PSA by age (95% percentile)

Age (years)	PSA (ng/mL)
40-49	0-2.5
50-59	0-3.5
60-69	0-4.5
70-79	0-6.5

Free PSA

• Free PSA helps to futher stratify likelihood of detecting prostate cancer for patients with a PSA of 4-10:

PSA	DRE abnormal?	Likelihood of prostate cancer	Free PSA %	Likelihood of prostate cancer (incorportating Free PSA data)
<2	Yes	5%
	No	1%
2-4	Yes	20%
	No	15%
4-10	Yes	45%
	No	25%	0-10	56%
			10-15	28%
			15-20	20%
			20-25	16%
			>25	8%
>10	Yes	>75%
	No	>50%

PCA3 (PROGENSA)

Basics

• PCA3 (prostate cancer gene 3) is a noncoding RNA whose expression is restricted to the prostate, overexpressed in >95% of prostate cancers
• PCA3 is overexpressed 60-100 times higher in prostate cancer cells as opposed to normal prostate gland cells
• PCA3 is independent of prostate volume, age, BPH, and prostatitis

Collection

• Requires "attentive DRE" involving firm pressure applied to the prostate--enough to depress the surface 0.5 to 1 cm from the base to apex and from lateral to median--3 strokes per lobe
• Obtain 20-30 mL first catch urine sample after attentive DRE
• 2.5 ml of urine is aliquoted to the testing containing and sent within 5 days to the PCA3 laboratory.

Analysis

• PCA3 and PSA mRNA are quantified, with PCA3/PSA x 1000 reported.
• PCA3.org

Oncotype DX Prostate

• Oncotype DX Prostate Genomic Health's Genomic Prostate Score (GPS) & prognostic prostate cancer assay

Prolaris

• Prolaris, Myriad's biomarker prognostic prostate cancer assay

Decipher

• Decipher, GenomeDx's genomic prognostic prostate cancer assay
  • "the Decipher Test uses the expression of these biomarkers to calculate the probability of clinical metastasis within 5 years of radical prostatectomy surgery, and within 3 years of successive PSA rise (biochemical recurrence)."