A Phase 3 interventional study of Risvutatug rezetecan (Ris-Rez) and Enzalutamide in Neoplasms, Prostate, sponsored by GlaxoSmithKline. Recruiting at 6 sites in 4 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
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Among 17 studies in Prostatic Neoplasms by GlaxoSmithKline — 3 open to participants now, 3 under way, 1 of them phase 3. Prostatic Neoplasms · GlaxoSmithKline.
Among the 17 studies in Prostatic Neoplasms by GlaxoSmithKline, this one is the 2nd largest by planned enrollment of the 13 interventional ones that give a count, is one of 2 that started in 2026, is one of 3 in phase 3, and was the 17th registered.
7,047 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.
Browse Prostatic Neoplasms studies →3 of the 17 studies in Prostatic Neoplasms by GlaxoSmithKline are open now, in 8 countries. Recruiting first, the newest first:
GlaxoSmithKline · Sites in United States, Australia, Canada and 5 more countries
Ages 18+ · Men only
GlaxoSmithKline · Sites in United States, Canada, France and 2 more countries
Ages 18+ · Men only
By country, each count listing its studies:
Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 3 · Phase 3 3 · Phase 4 3
First in 2003; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 684 is above the median of 60 across 5,349 interventional studies indexed under Prostatic Neoplasms.
Median enrollment 113 across the 13 interventional studies, 1 across the 4 observational. Of the 13 that completed or were terminated, 4 (31%) have results posted.
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GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
1 of the studies in Prostatic Neoplasms by GlaxoSmithKline that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06990880GlaxoSmithKlineA Study of GSK5458514 Administered Alone or In Combination With Other Anti-Cancer Agents in Participants With Prostate Cancer | 2027-10-26 |
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Among the 17 studies in Prostatic Neoplasms by GlaxoSmithKline, from their registry updates:
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This study aims to evaluate how well risvutatug rezetecan (Ris-Rez) works in treating prostate cancer compared to best supportive/standard of care (BSC) which may include a hormone therapy with an androgen receptor pathway inhibitors (ARPI), by checking whether it makes cancers smaller or disappear completely, if it helps participants live longer, and/or feel better. The study is also assessing whether Ris-Rez is safe and tolerated well by participants and aims to provide a better understanding of the side effects of the drug.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive Risvutatug rezetecan (Ris-Rez).
Biological: Risvutatug rezetecan (Ris-Rez)
Participants will receive physician's choice of best supportive/standard of care (BSC), with or without androgen receptor pathway inhibitors (ARPI) Enzalutamide, Abiraterone (with Prednisone or Prednisolone).
Drug: Enzalutamide · Drug: Abiraterone · Drug: Prednisone · Drug: Prednisolone
Risvutatug rezetecan (Ris-Rez) will be administered.
Enzalutamide will be administered.
Abiraterone will be administered.
Prednisone will be administered along with Abiraterone.
Prednisolone will be administered along with Abiraterone.
Radiographic Progression-Free Survival (rPFS) per PCWG3 by BICR
rPFS is defined as time from randomization to the first documented radiographic disease progression, per Prostate cancer clinical trials working group 3 (PCWG3) as assessed by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 169 weeks
Overall Survival (OS)
OS is defined as the time from randomization to date of death by any cause.
Time frame: Up to approximately 169 weeks
Time to Pain Progression (TTPP)
Time frame: Up to approximately 169 weeks
rPFS by Investigator assessment
rPFS is defined as time from randomization to the first documented radiographic disease progression per PCWG3 as assessed by Investigator or death due to any cause, whichever occurs first.
Time frame: Up to approximately 169 weeks
Confirmed Objective Response Rate (cORR)
cORR is defined as the percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) per PCWG3 by BICR.
Time frame: Up to approximately 169 weeks
Duration of Response (DoR)
DoR defined as the time from the date of first confirmed response (CR or PR) to the date of first documented PD per PCWG3 as assessed by BICR or death due to any cause, whichever comes first.
Time frame: Up to approximately 169 weeks
Time to Prostate-specific antigen (PSA) progression
Time to PSA progression is defined as the time from randomization to PSA progression according to PCWG3 criteria.
Time frame: Up to approximately 169 weeks
Prostate-specific antigen 50 (PSA50) response
PSA50 is defined as the proportion of participants having a ≥50% post-baseline PSA reduction from baseline with a consecutive confirmation assessment at least 3 weeks later.
Time frame: Up to approximately 169 weeks
Time to first Symptomatic Skeletal-Related Event (SSRE)
Time to first SSRE is defined as the time from randomization to first occurrence of any of the following symptomatic skeletal-related events: * Use of EBRT to prevent or relieve skeletal symptoms . * New symptomatic pathological bone fracture (vertebral or non-vertebral). * New symptomatic spinal cord compression. * Tumor-related orthopedic surgical intervention
Time frame: Up to approximately 169 weeks
Number of participants with adverse event (AEs), serious adverse event (SAEs), Adverse event of special interest (AESIs) by severity
Time frame: Up to approximately 169 weeks
Number of participants with AEs leading to dose modifications or study intervention discontinuation
Time frame: Up to approximately 169 weeks
Serum concentration of Ris-Rez (conjugated antibody and payload)
Time frame: Up to approximately 84 days
Number of participants with Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Ris-Rez
Time frame: Up to approximately 169 weeks
Titers of ADA against Ris-Rez
Time frame: Up to approximately 169 weeks
Participant-reported experience on study treatment
Number of participants who reported their experience with study treatment using validated questionnaires will be measured
Time frame: Up to approximately 169 weeks
Plan to share: Yes — Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
Data sharing details ↗ · www.gsk-studyregister.com
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Dec 2029, 39 months after the start.
Of 126 industry-sponsored phase 3 interventional studies under Prostatic Neoplasms, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 53. This study's planned 39 months is close to that.
Counting every sponsor, half of 265 studies reached it within 57 months; a quarter within 31 and three quarters within 100.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Risvutatug rezetecan