regimen-monograph

DOCEPRED

Intent

Palliative

Regimen Category

Evidence-Informed

Funding Program

ODB - General Benefit

Drugs Used

DOCEtaxel , prednisone

A - Regimen Name

DOCEPRED Regimen

DOCEtaxel-Prednisone

(castration sensitive)

Disease Site

Genitourinary - Prostate

Intent

Palliative

Regimen Category

Evidence-Informed :

Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR). Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.

Rationale and Uses

For treatment of metastatic castration sensitive prostate cancer. Funded by NDFP for patients who have visceral metastases and/or 4 or more bone metastases with at least one beyond pelvis and vertebral column.

Supplementary Public Funding

DOCEtaxel
New Drug Funding Program (Docetaxel - Hormone Sensitive Prostate Cancer) (NDFP Website)

prednisone
ODB - General Benefit (prednisone)

B - Drug Regimen

Androgen deprivation therapy, which may consist of

bilateral orchiectomy*
luteinising hormone-releasing hormone (LHRH) agonists*
LHRH antagonists*

(Anti-androgen use is recommended for short-term use to prevent tumour flare with LHRH agonists*)

_{* based on the STAMPEDE clinical trial.}

AND

DOCEtaxel

(Round to nearest 1 mg)

75 mg /m²

Day 1

_{^ In the CHAARTED trial, docetaxel was initiated within 4 months of starting ADT.}

The STAMPEDE trial also used prednisone in combination with docetaxel and ADT, until the completion of chemotherapy:

prednisone

(Round to nearest 5 mg)

5 mg

BID

C - Cycle Frequency

Docetaxel: REPEAT EVERY 21 DAYS for 6 cycles

Androgen Deprivation Therapy: Until disease progression or unacceptable toxicity (used for at least 2 years in the STAMPEDE clinical trial)

D - Premedication and Supportive Measures

Antiemetic Regimen:

Low

Other Supportive Care:

• DEXAMETHASONE Pre- & Post medication should be administered to prevent anaphylaxis and fluid retention. (i.e. Dexamethasone 8mg PO 12 h, 3 h and 1 h pre-docetaxel; OR dexamethasone 8 mg PO in the evening before the infusion of docetaxel, on the day of docetaxel infusion, and on the next day.)

Also refer to CCO Antiemetic Summary

E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated. The following recommendations have been adapted from clinical trials or product monographs and could be considered. See appendix 6 for general recommendations.

Dosage with toxicity

Toxicity (worst in previous cycle)	Docetaxel dose modification*
Febrile neutropenia / Grade 4 ANC ≥ 7 d	75%
Grade 3 skin/ neuro/ major organ/ non-hematologic toxicity	75%
Any occurrence of cystoid macular edema	Hold and investigate; refer patient promptly for ophthalmic examination. Discontinue if confirmed.
Grade 4 skin/ neuro/ major organ/ non-hematologic toxicity OR Recurrence of Grade 3 toxicity after prior dose reduction	Discontinue
_{* Do not retreat until ANC ≥ 1.5 x 10}⁹_{/L, platelets ≥ 100 x 10}⁹_{/L, and toxicity ≤ grade 2.}

Hypersensitivity

Hypersensitivity reactions may occur within a few minutes following the initiation of docetaxel infusion.

Toxicity	Action
Mild hypersensitivity reaction	↓ infusion rate (and/ or hold) and use beta-agonists, antihistamines, antipyretics, and/or corticosteroids as appropriate. Consider premedication for next infusion.
Moderate hypersensitivity reaction	Hold and use beta-agonists, antihistamines, antipyretics, and/or corticosteroids as appropriate; complete infusion at ↓ rate if possible. Use premedication for next infusion.
Severe hypersensitivity reaction or Pulmonary Toxicity	Hold and manage symptoms aggressively with beta-agonists, antihistamines, antipyretics, and/or corticosteroids. Discontinue permanently and do not rechallenge

Hepatic Impairment

	AST/ALT		Alk Phosp		Bilirubin	Docetaxel Dose
Mild-moderate	> 1.5 X ULN	AND	> 2.5 x ULN			75%
Severe	> 3.5 x ULN	AND	> 6 x ULN	OR	> ULN	Do not treat. Discontinue if treatment already started.

Renal Impairment

No adjustment required.

F - Adverse Effects

Refer to DOCEtaxel drug monograph(s) for additional details of adverse effects.

Most Common Side Effects	Less Common Side Effects, but may be Severe or Life-Threatening
Myelosuppression ± infection or bleeding (may be severe) Hypersensitivity reactions (may be severe) Fluid retention (may be severe) Neuropathy (may be severe) Cutaneous effects (including nails, may be severe) Alopecia GI (nausea, vomiting, stomatitis, diarrhea) Fatigue Musculoskeletal pain Lacrimation/tear duct obstruction	Secondary malignancies Cardiotoxicity, arrhythmia Pneumonitis GI obstruction, perforation, hemorrhage Venous thromboembolism Arterial thromboembolism DIC Seizures ↑ LFTs Cystoid macular edema

G - Interactions

Refer to DOCEtaxel drug monograph(s) for additional details

H - Drug Administration and Special Precautions

Refer to DOCEtaxel drug monograph(s) for additional details

I - Recommended Clinical Monitoring

Recommended Clinical Monitoring

CBC, including nadir counts; baseline and before each dose
Liver function tests; Baseline and routine
Regular toxicity assessment of infection, bleeding, neurotoxicity, fluid retention, hypersensitivity, lethargy, cutaneous reactions, thromboembolism, cardiovascular, musculoskeletal pain, ophthalmic, GI or respiratory effects;
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

J - Administrative Information

Approximate Patient Visit

2 hours

Pharmacy Workload (average time per visit)

23.936 minutes

Nursing Workload (average time per visit)

54.167 minutes

K - References

Gravis G, Fizazi K, Joly F, et al. Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. Lancet Oncol 2013 Feb;14(2):149-58.

James ND, Sydes MR, Mason MD, et al. Docetaxel and/or zoledronic acid for hormone-naïve prostate cancer: First overall survival results from STAMPEDE (NCT00268476). J Clin Oncol 2015;33(suppl; abstr 5001). Also refer to http://www.stampedetrial.org/

Sweeney C, Chen YH, Carducci MA, et al. Impact on overall survival (OS) with chemohormonal therapy versus hormonal therapy for hormone-sensitive newly metastatic prostate cancer (mPrCa): An ECOG-led phase III randomized trial. J Clin Oncol. 2014;32(5s):(suppl; abstr LBA2).

Docetaxel drug monograph. Cancer Care Ontario, 2014.

October 2017 Replaced regimen category with evidence-informed

M - Disclaimer

Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
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Last Updated: July 27, 2026

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