Genitourinary SACT Regimens

The information contained in these regimens is a statement of consensus of NCCP and ISMO or IHS professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. The treatment regimen to be used should take into account factors such as histology, molecular pathology, age, performance status, co-morbidities and the patient’s preference. Each treatment regimen has advantages and disadvantages, and there may be more than one good option. In addition, treatment choices can change over time as more evidence becomes available. Use of these documents is the responsibility of the prescribing clinician and is subject to the HSE.ie terms of use.

Please email any comments or feedback on these regimens to oncologydrugs@cancercontrol.ie.

For information on open clinical trials please refer to the Cancer Trials Ireland website and also to basket trials.

Bladder Cancer Chemotherapy Regimens

PD-L1 IHC request Form Urothelial Cancer

Regimen Name Indication

Atezolizumab Monotherapy - 21 day

Regimen

00544b

Treatment of adult patients with locally advanced or metastatic
urothelial carcinoma (UC) after prior platinum-containing
chemotherapy.

00544c

Treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are considered cisplatin ineligible and whose tumours have a PD-L1 expression ≥5%

Atezolizumab 1680mg Monotherapy - 28 Day

Regimen

00593b

Treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) after prior platinum-containing chemotherapy.

00593c

Treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are considered cisplatin ineligible and whose tumours have a PD-L1 expression ≥5%.

Avelumab Monotherapy

Regimen

00535

First-line maintenance treatment of adult patients with locally advancedor metastatic urothelial carcinoma (UC) who are progression-free following platinum based chemotherapy

CISplatin 40mg/m2 Weekly with Radiotherapy (RT)

Regimen

00385b

Chemoradiation treatment for locally advanced bladder cancer.

Cisplatin, Methotrexate and Vinblastine (CMV) Therapy

Regimen

00337a

Neoadjuvant treatment of muscle invasive transitional cell carcinoma (TCC) of the urothelium.

Enfortumab vedotin Monotherapy

Regimen

00846a

For the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who have previously received a platinum-containing chemotherapy and a programmed death receptor 1 (PD-1) or programmed death ligand 1 inhibitor (PD-L1). 

5-Fluorouracil (5 day) and mitoMYcin Chemoradiation Therapy

Regimen

00450a

Treatment of muscle invasive bladder cancer in patients.

Gemcitabine (1000mg/m2) and CISplatin (35mg/m2)
Therapy- 21 day

Regimen

00622a

Treatment of patients with locally advanced or metastatic transitional cell carcinoma (TCC) of the urothelium in patients with impaired renal function.

Gemcitabine (1000mg/m2) and CISplatin (70mg/m2)
Therapy- 21 day

Regimen

00628a

Adjuvant treatment of upper tract urothelial carcinoma.

Gemcitabine (1000mg/m2) and CARBOplatin (AUC5) Therapy-21 day

Regimen

00310a

Treatment of patients with locally advanced or metastatic transitional cell carcinoma (TCC) of the urothelium where CISplatin is contraindicated.*

Gemcitabine (1000mg/m2) and CISplatin (70mg/m2) Therapy-28 day

Regimen

00282a

Treatment of patients with locally advanced or metastatic transitional cell carcinoma (TCC) of the urothelium.

Methotrexate, VinBLAStine, DOXOrubicin, CISplatin (MVAC) Therapy-14 days

Regimen

00333a

Locally advanced or metastatic transitional cell carcinoma (TCC) of the urothelium.

Methotrexate, vinBLAStine, DOXOrubicin, CISplatin (MVAC) Therapy-28 days

Regimen

00338a

Neoadjuvant treatment of muscle invasive transitional cell carcinoma (TCC) of the urothelium.

00338b

Adjuvant treatment of muscle invasive TCC of the urothelium.

00338c

Locally advanced or metastatic TCC of the urothelium.

PACLitaxel Monotherapy 80mg/m2 Day 1, 8, 15 and 22 - 28 Day

Regimen

00226e

Second line chemotherapy for metastatic bladder cancerii.

PACLitaxel 80mg/m2 Day 1, 8 and 15 Monotherapy-28 Day

Regimen

00621e

Second line chemotherapy for metastatic bladder cancer.

Pembrolizumab 200mg Monotherapy

Regimen

00455e

As monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy.

00455f

As monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy whose tumours express PD-L1 with a combined positive score (CPS) ≥10.

00455m

For the adjuvant treatment of adult patients with renal cell carcinoma (RCC) at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Pembrolizumab 400mg Monotherapy

Regimen

00558e

As monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy.

00558f

As monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy whose tumours express PD-L1 with a combined positive score (CPS) ≥10.

00558m

For the adjuvant treatment of adult patients with renal cell carcinoma (RCC) at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Germ Cell Chemotherapy Regimens

Regimen Name Indication

Bleomycin, Etoposide and CISplatin (BEP) Therapy

Regimen

00300a

Adjuvant treatment of high risk (vascular invasion carcinoma) stage 1 non-seminoma germ cell tumour.

00300b

Metastatic germ cell tumours of the testis.

00300c

Advanced stage or metastatic germ cell tumours (dysgerminoma) of the ovaries.

00300d

Extra-gonadal germ cell tumours.

CARBOplatin (AUC7) and Etoposide - Autologous Conditioning Germ Cell Tumour Regimen

Regimen

00453a

Treatment of metastatic relapsed/refractory germ cell tumours.

Etoposide and CISplatin 20mg/m2 (EP) 5 Day Therapy

Regimen

00301a

Treatment of good prognosis (IGCCCG criteria) metastatic germ cell tumours (both non-seminoma and seminoma).

PACLitaxel, Ifosfamide, and CISplatin (TIP) Therapy

Regimen

00602a

Treatment of relapsed / refractory metastatic testicular germ cell cancer.

Prostate Chemotherapy Regimens

Regimen Name Indication

Abiraterone and Prednisolone Therapy

Regimen

00103a

Treatment of mCRPC which has progressed on or after a docetaxel-based chemotherapy regimen.

00103b

Treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.

Abiraterone 1000mg and Prednisolone 5mg Therapy

Regimen

00577a

Abiraterone is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).

Apalutamide Therapy

Regimen

00574a

Apalutamide is indicated for the treatment of adult men with non-metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.

00574b

For the treatment of patients with metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy.

Bicalutamide Therapy

Regimen

00482

Treatment of advanced prostate cancer in combination with luteinizing-hormone releasing hormone (LHRH) analogue therapy or surgical castration.

Cabazitaxel and prednisoLONE

Regimen

00101a

Cabazitaxel is indicated in combination with prednisone or prednisolone for the treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.

Darolutamide Therapy

Regimen

00693a

Treatment of adult men with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.

Degarelix Therapy

Regimen

00481a

Treatment of adult male patients with advanced hormone-dependent prostate cancer.

Denosumab 120mg Therapy

Regimen

00741a

For the prevention of skeletal related events in adult patients with malignancies involving bone.

Docetaxel Monotherapy 50mg/m2 – 14 day cycle

Regimen

00313a

In combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.

DOCEtaxel Monotherapy 75mg/m2 - 21 day cycle

Regimen

00203b

First line in high risk non metastic castration sensitive prostate cancer.

00203c

First line in metastatic castration sensitive prostate cancer.

DOCEtaxel 75 mg/m2 – Prednisolone Combination Therapy

Regimen

00546a

In combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.

Enzalutamide Monotherapy

Regimen

00233a

Treatment of adult men with metastatic castration-resistant prostate cancer whose disease has progressed on or after docetaxel therapy.

00233b
Treatment of adult men with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.

00233c

The treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC).

Goserelin 3.6mg Therapy -28 day

Regimen

00478a

Treatment of locally advanced or metastatic hormone sensitive prostate cancer.

Goserelin 10.8mg Therapy -12week

Regimen

00477a

Treatment of locally advanced or metastatic hormone sensitive prostate cancer.

Leuprorelin 3.75mg Therapy-28 day

Regimen

00494a

Management of prostatic carcinoma for which a suppression of testosterone is indicated.

Leuprorelin 7.5mg Therapy-28 day

Regimen

00490a

Treatment of hormone dependent advanced prostate cancer. 

00490b 

Treatment of high-risk localized and locally advanced hormone dependent prostate cancer in combination with radiotherapy.

Leuprorelin 11.25mg Therapy-12 week

Regimen

00492a

Management of prostatic carcinoma for which a suppression of testosterone is indicated.

Leuprorelin 22.5mg Therapy-12 week

Regimen

00479a

Treatment of hormone dependent advanced prostate cancer.

00479b 

Treatment of high-risk localized and locally advanced hormone dependent prostate cancer in combination with radiotherapy.

Leuprorelin 30mg-24 week

Regimen

00493a

Treatment of locally advanced or metastatic hormone dependent advanced prostate cancer.

Leuprorelin 45mg Therapy-24 week

Regimen

00491a 

Treatment of hormone dependent advanced prostate cancer. 

00491b

Treatment of high-risk localized and locally advanced hormone dependent prostate cancer in combination with radiotherapy.

Olaparib (Tablet) Monotherapy

Regimen

00588g

As monotherapy for the treatment of adult patients with metastatic castration resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.

Niraparib and Abiraterone acetate (Akeega®) and prednisoLONE Therapy

Regimen

 00848a

Niraparib in combination with abiraterone acetate (Akeega®) and predniSONE/prednisoLONE for the treatment of adults with metastatic castration resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) in whom chemotherapy is not clinically indicated

Radium 223 Therapy

Regimen

00257a

As monotherapy or in combination with LHRH analogues for the treatment of adults with progressive castration-resistant metastatic prostate cancer (mCRPC, symptomatic bone metastases and no extensive visceral metastases after at least two prior lines of systemic therapy for mCRPC (other than LHRH analogues), or ineligible for any available licensed systemic mCRPC treatment.

Relugolix Therapy

Regimen

00830a

Treatment of adult patients with advanced hormone-sensitive prostate cancer (HSPC).

Triptorelin 3mg Therapy-28 day

Regimen

00489a 

Treatment of locally advanced or metastatic hormone dependent advanced prostate cancer.

Triptorelin 11.25mg Therapy-12 week

Regimen

00480a

Treatment of locally advanced or metastatic hormone dependent advanced prostate cancer.

Triptorelin 22.5mg Therapy-24 week

Regimen

00488a

Treatment of locally advanced or metastatic hormone dependent advanced prostate cancer.

Zoledronic Acid Therapy-28 days

Regimen

00723a

Prevention of skeletal related events in malignancies involving bone metastases

Zoledronic Acid Therapy-3 monthly

Regimen

00724a

Prevention of skeletal related events in malignancies involving bone metastases

Zoledronic Acid Therapy-6 monthly

Regimen

00725a

Prevention of skeletal related events in malignancies involving bone metastases

 

Renal Chemotherapy Regimens

Regimen Name Indication

Axitinib Therapy

Regimen

00104a

Treatment of adult patients with advanced RCC after failure, on a previous line of therapy, i.e. treatment with SUNItinib, or a cytokine.

Atezolizumab 840mg Monotherapy - 14 day

Regimen

00592a

Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy.

00592b

Treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) after prior platinum-containing chemotherapy.

00592c

Treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are considered cisplatin ineligible and whose tumours have a PD-L1 expression ≥5%.

Bevacizumab 10 mg/kg –14 days

Regimen

00212d

In combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.

Cabozantinib Therapy

Regimen

00518a

Treatment of advanced renal cell carcinoma (RCC) in adults following prior VEGF targeted therapy.

Everolimus Therapy

Regimen

00320a

Treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.

Pembrolizumab 200mg and Axitinib Therapy

Regimen

00583a

Pembrolizumab in combination with axitinib for the first-line treatment of advanced renal cell carcinoma (RCC) in adults.

Nivolumab 240mg Monotherapy - 14 Days

Regimen

00483b

As monotherapy for the treatment of advanced renal cell carcinoma (RCC) after prior therapy in adults.

Nivolumab 480mg Monotherapy -28 Days

Regimen

00484b 

As monotherapy for the treatment of advanced renal cell carcinoma (RCC) after prior therapy in adults.

Nivolumab 3mg/kg with Ipilimumab 1mg/kg Therapy

Regimen

00551a

Nivolumab in combination with ipilimumab for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (RCC).

PAZOPanib Therapy

Regimen

00445a

First line treatment of advanced Renal Cell Carcinoma (RCC) in adults and for patients who have received prior cytokine therapy for advanced disease.

SORAfenib Therapy

Regimen

00294b

Treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

SUNitinib 50mg Therapy

Regimen

00325b

Treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.

SUNitinib 50mg (21 Days) Therapy

Regimen

00719b

Treatment of clear-cell type metastatic renal cell carcinoma (MRCC).

Temsirolimus Monotherapy

Regimen

00326a

First-line treatment of adult patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors.

Tivozanib Therapy

Regimen

00564a

Tivozanib for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.