Pfizer MEVPRO Prostate Cancer Clinical Trials

Help advance metastatic prostate cancer treatment research

For more information about the MEVPRO study medicine, please watch the short video below.

Explore Pfizer’s MEVPRO Clinical Trials as potential options for people with prostate cancer

  • Recruiting
MEVPRO-1
For people with abiraterone-resistant metastatic prostate cancer
A Phase 3 clinical trial evaluating the investigational medicine in combination with enzalutamide compared to enzalutamide or docetaxel alone in adults with mCRPC previously treated with abiraterone acetate.
Study details
MEVPRO-1 is a Phase 3, randomized, open-label clinical trial to evaluate an investigational medicine for men with metastatic castration-resistant prostate cancer (mCRPC) that has progressed after treatment with abiraterone acetate. MEVPRO-1 will investigate whether investigational medicine in combination with enzalutamide is superior to either enzalutamide or docetaxel in prolonging radiographic progression-free survival in the mCRPC setting.
Approximately 600 participants across approximately 174 investigational sites will be randomly assigned in a 1:1 ratio to Arm A or Arm B.
  • Investigational Arm A:
    Investigational medicine 875 mg BID plus
    enzalutamide 160 mg QD
  • Control Arm B: Study doctor’s choice of enzalutamide 160 mg QD OR docetaxel* 75 mg/m2 IV every cycle (21 days) for up to a maximum of 10 cycles. 
*Docetaxel is given in combination with prednisone or prednisolone, 5 mg BID for 21 days, and premedication of oral dexamethasone 8 mg at 12 hours, 3 hours, and 1 hour (or IV dexamethasone per standard of care) before the docetaxel infusion. 
Participants will receive investigational treatment until radiographic disease progression, unacceptable toxicity, protocol violation, withdrawal, or study termination. The length of participation in MEVPRO-1 will vary depending on how well participants tolerate the study treatment or time to disease progression.

The study includes a 28-day screening period, the treatment period, and a safety follow-up visit that occurs within 28-35 days of treatment discontinuation and the long term follow-up period. The treatment period in the study will consist of cycles of 3 weeks (docetaxel group) or 4 weeks (enzalutamide groups). Participants receiving investigational medicine and enzalutamide or enzalutamide alone will attend 2 study visits in Cycles 1 and 2, then 1 study visit per cycle thereafter. Participants receiving standard-of-care docetaxel will attend 1 study visit per cycle for up to 10 cycles.

Long-term safety follow-up will consist of visits every 12 weeks from safety follow-up visit until the study is complete, which may take many years, or until the participant withdraws consent.
Participant eligibility
  • Key inclusion criteria:
  • Male participants ≥18 years of age at screening.
  • Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features (neuroendocrine differentiation and other histologic components are permitted if adenocarcinoma is the primary histology).
  • Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
  • Progressive disease in the setting of surgical or medical castration as defined by 1 or more of the following 3 criteria:
    • PSA progression defined as a minimum of two rising PSA levels with an interval of ≥1 week between each determination, within the last 12 months. The PSA value at the Screening must be ≥1 ng/mL if confirmed rise in PSA is the only indication of progression per PCWG3 criteria;
    • Soft tissue disease progression as defined by RECIST v1.1.
    • Bone disease progression defined by PCWG3 with 2 or more new metastatic bone lesions on a whole-body radionuclide bone scan.
  • Note: Evidence of disease progression on treatment with at least 12 weeks of abiraterone acetate in the metastatic castration-sensitive prostate (mCSPC) cancer or first-line mCRPC setting.
  • Key exclusion criteria:
  • Treatment with cytotoxic chemotherapy, radioligand therapy (i.e. 177Lu-PSMA-617, radium-223), ARSI, PARP monotherapy or other systemic anticancer treatment (approved or experiment compounds such as antibody therapy immunotherapy, gene therapy, angiogenesis inhibitors, CDK4/6 inhibitors, EZH2 inhibitors) since becoming castration-resistant.
  • History of any other cancer in the last 3 years (except for some skin cancers or early-stage cancers that have been cured).
  • Clinically significant cardiovascular disease, renal disease or liver disease.
  • Prior treatment for prostate cancer at any stage with any cytotoxic chemotherapy, radioligand therapy, ARSi (including enzalutamide, apalutamide, darolutamide), PARP monotherapy or other systemic anti-cancer treatment.
  • Major surgery or palliative localized radiation therapy within 14 days before randomization.

Please speak to the study team or a Pfizer Field Medical representative for the full eligibility criteria.

Thank you for considering this clinical trial.

  • Recruiting
MEVPRO-2
For people who have not tried hormonal therapy or chemotherapy for metastatic castrate-resistant prostate cancer
A Phase 3 clinical trial evaluating the investigational medicine in combination with enzalutamide compared to a placebo in combination with enzalutamide in adults with mCRPC who have not tried hormonal therapy or chemotherapy in the castrate-resistant setting.
Study details
MEVPRO-2 is a Phase 3, randomized, double-blind clinical trial of an investigational medicine in combination with enzalutamide compared to a placebo in combination with enzalutamide in adults with mCRPC (metastatic castration resistant prostate cancer).
MEVPRO-2 will investigate whether investigational medicine plus enzalutamide can delay or prevent anti-androgen resistance to provide superior clinical benefit compared to enzalutamide alone in participants with mCRPC who have not tried hormonal therapy or chemotherapy in the castrate-resistant setting.
Approximately 900 participants will be randomly assigned in a 1:1 ratio to Arm A or Arm B.
  • Investigational Arm A:
    Investigational medicine 875 mg BID plus
    enzalutamide 160 mg QD    
  • Control Arm B:
    Placebo tablets BID plus
    enzalutamide 160 mg QD
Participants will receive investigational treatment until radiographic disease progression, unacceptable toxicity, protocol violation, withdrawal, or study termination. The length of participation in MEVPRO-2 will vary depending on how well participants tolerate the study treatment or time to disease progression.

The study includes a 28-day screening period, the treatment period, safety follow-up visit that occurs within 28–35 days of treatment discontinuation and the long term follow-up period. The treatment period in the study will consist of cycles every 28 days. Participants will attend visits every 2 weeks until Week 9, then every 4 weeks until Week 53, and then every 8 weeks while receiving the study medicine.

Long-term follow-up will consist of visits every 12 weeks from the safety follow-up visit until the study is complete, which may take many years, or until the participant withdraws consent.
Participant eligibility
  • Key inclusion criteria:
  • Male participants ≥18 years of age at screening.
  • Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features (neuroendocrine differentiation and other histologic components are permitted if adenocarcinoma is the primary histology).
  • Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
  • Progressive disease in the setting of medical or surgical castration as defined by meeting 1 or more of the following 3 criteria:
    • Prostate specific antigen (PSA) progression defined by rising PSA of at least 2 consecutive rises in most recent PSA to be documented over a reference value (measure 1) taken at least 7 days apart within the last 12 months. If the third PSA measure is not greater than the second measure, a fourth PSA measure is required to be taken and be greater than the second measure. The last of these PSA values, obtained before randomization must be ≥1 μg/L if qualifying only by PSA progression.
    • Soft tissue disease progression as defined by RECIST 1.1.
    • Bone disease progression defined by PCWG3 with 2 or more new metastatic bone lesions on a whole-body radionuclide bone scan.
  • Key exclusion criteria:
  • Participants must be treatment naïve at the mCRPC stage, e.g., no cytotoxic chemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4/6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, androgen receptor signalling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment. Treatment with first-generation antiandrogen (ADT) agents is allowed if discontinued prior to the first dose of study medication. Prior docetaxel in mCSPC is allowed.
  • History of any other cancer in the last 3 years (except for some skin cancers or early-stage cancers that have been cured).
  • Clinically significant cardiovascular disease, renal disease or liver disease.
  • Major surgery or palliative localized radiation therapy within 14 days before randomization.
  • Prior treatment with opioids for pain related to either primary prostate cancer or metastasis within 28 days prior to randomization. 

Please speak to the study team or a Pfizer Field Medical representative for the full eligibility criteria.

Thank you for considering this clinical trial.

  • Recruiting
MEVPRO-3
For people with metastatic castration-sensitive prostate cancer who have not received treatment for their castration-sensitive cancer, except for androgen-deprivation (chemical or surgical) therapy
A Phase 3 clinical trial evaluating the investigational medicine in combination with enzalutamide compared to a placebo in combination with enzalutamide in adults with treatment naïve mCSPC.
Study details
MEVPRO-3 is a Phase 3, randomized, double-blind clinical trial of an investigational medicine in combination with enzalutamide compared to a placebo in combination with enzalutamide in adults with mCSPC (metastatic castration-sensitive prostate cancer).  

MEVPRO-3 will investigate whether the investigational medicine plus enzalutamide can delay or prevent anti-androgen resistance to provide superior clinical benefit compared to placebo plus enzalutamide in participants with mCSPC who have not tried novel hormonal therapy or chemotherapy in the castration-sensitive setting. 

Approximately 1000 participants will be randomly assigned in a 1:1 ratio to Arm A or Arm B.  
  • Investigational Arm A:
    Investigational medicine 875 mg twice daily (BID)
    plus enzalutamide 160 mg once daily (QD)   
  • Control Arm B:
    Placebo tablets BID plus enzalutamide 160 mg QD
Participants will receive investigational treatment until radiographic disease progression, unacceptable toxicity, protocol violation, withdrawal or study termination. The length of participation in MEVPRO-3 will vary depending on how well participants tolerate the study treatment or time to disease progression.
The study includes a 28-day screening period, the treatment period, a 28 to 35-day safety follow-up and a long-term follow-up period.
The treatment period in the study will consist of cycles every 4 weeks (28 days). Participants will attend visits every 4 weeks until Cycle 14, and then every 8 weeks thereafter while receiving the study medicine. Participants will have imaging assessments every 8 weeks until Week 25, then every 12 weeks thereafter.
Long-term safety follow-up will consist of visits every 8 weeks until Week 25, then every 12 weeks thereafter until the study is complete, which may take many years, or until the participant withdraws consent. 
Participant eligibility
  • Key inclusion criteria:
  • Male participants ≥18 years of age at screening.
  • Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
  • Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
  • Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI scan (for soft tissue/visceral disease). 
    • Measurable soft tissue/visceral disease (per RECIST v1.1) is required if there is not an evaluable bone lesion (per PCWG3 criteria).
    • For participants with measurable soft tissue disease only, regional lymph node disease (e.g. below aortic bifurcation) alone does not qualify the participant for the study.
    • PET and SPECT are not evaluable imaging modalities for this study.
    • A bone scan showing intense symmetric activity in the bones (referred to as a superscan) is not considered evaluable.
  • Participants must have ECOG PS 0 or 1.
  • Participants cannot have received any cytotoxic chemotherapy, ARPIs (e.g. enzalutamide, apalutamide, abiraterone acetate or darolutamide) or any other systemic anticancer therapies for mCSPC, with the following exceptions:
    • ADT (chemical or surgical) must be started prior to randomization and must continue throughout the study. Prior therapy with up to 3 months of ADT (with or without antiandrogens) is allowed with no radiographic evidence of disease progression or rising PSA levels prior to Day 1.
    • Treatment with estrogens, cyproterone acetate or first-generation antiandrogens is allowed until randomization, but must be discontinued prior to randomization.
    • Participants may have received 1 course of palliative radiation or surgery for symptomatic control secondary to prostate cancer, which should be completed at least 2 weeks prior to randomization.
      Note: Radical prostatectomy or definitive radiotherapy to the primary prostate tumour for mCSPC with curative intent is not permitted.
  • Key exclusion criteria:
  • Prior treatment with:
    • ADT in the adjuvant/neoadjuvant setting, where the completion of ADT was <12 months prior to randomization and the total duration of ADT was >36 months.
    • ARPIs such as abiraterone, apalutamide, darolutamide, enzalutamide or other investigational ARPI’s.
    • Cytochrome P17 enzyme inhibitors such as oral ketoconazole as anticancer treatments for prostate cancer.
    • Chemotherapy including docetaxel or immunotherapy for prostate cancer.
    • Radiopharmaceuticals (i.e. 177Lu-PSMA-617, radium-223).
    • CDK4/6 inhibitors.
    • Any other anticancer treatment for metastatic prostate cancer, excluding palliative radiotherapy/surgery and ADT as discussed above.
  • History of any other cancer in the last 3 years (except for some skin cancers or early-stage cancers that have been cured).
  • Clinically significant cardiovascular disease, renal disease or liver disease.

Please speak to the study team or a Pfizer Field Medical representative for the full eligibility criteria.

Thank you for considering this clinical trial.

Find a study site near you

The Pfizer MEVPRO Prostate Cancer Clinical Trials are taking place at research sites in multiple countries worldwide. 
To find your nearest study site, please enter your postal code and select the optimal distance to view on the map from the drop-down menu:

      Thank you for considering Pfizer’s MEVPRO Prostate Cancer Clinical Trials.

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