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Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05050084
Recruitment Status : Recruiting
First Posted : September 20, 2021
Last Update Posted : March 28, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NRG Oncology

Study Description
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Brief Summary:
This phase III trial uses the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient's cancer aggressiveness. The Decipher risk score evaluates a prostate cancer tumor for its potential for spreading. In patients with low risk scores, this trial compares radiation therapy alone to the usual treatment of radiation therapy and hormone therapy (androgen deprivation therapy). Radiation therapy uses high energy x-rays or particles to kill tumor cells and shrink tumors. Androgen deprivation therapy blocks the production or interferes with the action of male sex hormones such as testosterone, which plays a role in prostate cancer development. Giving radiation treatment alone may be the same as the usual approach in controlling the cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy. In patients with higher Decipher gene risk, this trial compares the addition of darolutamide to usual treatment radiation therapy and hormone therapy, to usual treatment. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. The addition of darolutamide to the usual treatment may better control the cancer and prevent it from spreading.

Condition or disease Intervention/treatment Phase
Prostate Adenocarcinoma Drug: Bicalutamide Drug: Buserelin Drug: Darolutamide Drug: Degarelix Drug: Flutamide Drug: Goserelin Drug: Histrelin Drug: Leuprolide Radiation: Radiation Therapy Drug: Relugolix Drug: Triptorelin Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)
Actual Study Start Date : November 3, 2021
Estimated Primary Completion Date : April 30, 2032
Estimated Study Completion Date : April 30, 2037

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (RT)
Patients undergo RT using a recognized regimen (2-3 days a week or 5 days a week for 2-11 weeks) in the absence of disease progression or unacceptable toxicity.
 Radiation: Radiation Therapy
Undergo RT
Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation
Experimental: Arm II (RT, ADT)
Patients undergo RT as Arm I. Patients also receive ADT consisting of leuprolide, goserelin, buserelin, histrelin, triptorelin, degarelix, or relugolix at the discretion of the treating physician, for 6 months in the absence of disease progression or unacceptable toxicity. Patients may also receive bicalutamide or flutamide for 0, 30 or 180 days.
 Drug: Bicalutamide
Anti-androgen
Other Names:
  • Casodex
  • Cosudex
  • ICI 176,334
  • ICI 176334

Drug: Buserelin
GnRH agonist
Other Names:
  • 6-[O-(1,1-Dimethylethyl)-D-serine]-9-(N-ethyl-L-prolinamide)-10-deglycinamide-luteinizing Hormone-releasing Factor (Pig)
  • BSRL
  • Busereline
  • Etilamide
  • HOE 766
  • ICI 123215
  • S74-6766

Drug: Degarelix
GnRH antagonist
Other Names:
  • FE200486
  • Firmagon

Drug: Flutamide
Anti-androgen
Other Names:
  • 4'-Nitro-3'-trifluoromethylisobutyranilide
  • Apimid
  • Cebatrol
  • Chimax
  • Cytomid
  • Drogenil
  • Euflex
  • Eulexine
  • Flucinom
  • Flucinome
  • Flugerel
  • Fluken
  • Flulem
  • FLUT
  • Fluta-Gry
  • Flutabene
  • Flutacan
  • Flutamex
  • Flutamin
  • Flutan
  • Flutaplex
  • Fugerel
  • Grisetin
  • Niftolide
  • Oncosal
  • Profamid
  • Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-
  • Prostacur
  • Prostadirex
  • Prostica
  • Prostogenat
  • Sch 13521
  • Tafenil
  • Tecnoflut
  • Testotard

Drug: Goserelin
GnRH agonist
Other Name: ICI-118630

Drug: Histrelin
GnRH agonist

Drug: Leuprolide
GnRH agonist
Other Name: Leuprorelin

Radiation: Radiation Therapy
Undergo RT
Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation

Drug: Relugolix
GnRH antagonist
Other Names:
  • N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea
  • Orgovyx
  • TAK 385
  • TAK-385

Drug: Triptorelin
GnRH agonist
Other Names:
  • 6-D-Tryptophan-LH-RH
  • 6-D-Tryptophanluteinizing Hormone-releasing Factor
  • AY-25650
  • CL-118,532
  • Detryptoreline
Experimental: Arm III (RT, ADT)
Patients receive treatment as in Arm II.
 Drug: Bicalutamide
Anti-androgen
Other Names:
  • Casodex
  • Cosudex
  • ICI 176,334
  • ICI 176334

Drug: Buserelin
GnRH agonist
Other Names:
  • 6-[O-(1,1-Dimethylethyl)-D-serine]-9-(N-ethyl-L-prolinamide)-10-deglycinamide-luteinizing Hormone-releasing Factor (Pig)
  • BSRL
  • Busereline
  • Etilamide
  • HOE 766
  • ICI 123215
  • S74-6766

Drug: Degarelix
GnRH antagonist
Other Names:
  • FE200486
  • Firmagon

Drug: Flutamide
Anti-androgen
Other Names:
  • 4'-Nitro-3'-trifluoromethylisobutyranilide
  • Apimid
  • Cebatrol
  • Chimax
  • Cytomid
  • Drogenil
  • Euflex
  • Eulexine
  • Flucinom
  • Flucinome
  • Flugerel
  • Fluken
  • Flulem
  • FLUT
  • Fluta-Gry
  • Flutabene
  • Flutacan
  • Flutamex
  • Flutamin
  • Flutan
  • Flutaplex
  • Fugerel
  • Grisetin
  • Niftolide
  • Oncosal
  • Profamid
  • Propanamide, 2-Methyl-N-(4-nitro-3-(trifluoromethyl)phenyl)-
  • Prostacur
  • Prostadirex
  • Prostica
  • Prostogenat
  • Sch 13521
  • Tafenil
  • Tecnoflut
  • Testotard

Drug: Goserelin
GnRH agonist
Other Name: ICI-118630

Drug: Histrelin
GnRH agonist

Drug: Leuprolide
GnRH agonist
Other Name: Leuprorelin

Radiation: Radiation Therapy
Undergo RT
Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation

Drug: Relugolix
GnRH antagonist
Other Names:
  • N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea
  • Orgovyx
  • TAK 385
  • TAK-385

Drug: Triptorelin
GnRH agonist
Other Names:
  • 6-D-Tryptophan-LH-RH
  • 6-D-Tryptophanluteinizing Hormone-releasing Factor
  • AY-25650
  • CL-118,532
  • Detryptoreline
Experimental: Arm IV (RT, ADT, darolutamide)
Patients receive RT and ADT as in Arm II. Patients also receive darolutamide PO BID on days 1-90. Treatment repeats every 90 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
 Drug: Buserelin
GnRH agonist
Other Names:
  • 6-[O-(1,1-Dimethylethyl)-D-serine]-9-(N-ethyl-L-prolinamide)-10-deglycinamide-luteinizing Hormone-releasing Factor (Pig)
  • BSRL
  • Busereline
  • Etilamide
  • HOE 766
  • ICI 123215
  • S74-6766

Drug: Darolutamide
Anti-androgen
Other Names:
  • Antiandrogen ODM-201
  • BAY 1841788
  • BAY-1841788
  • BAY1841788
  • Nubeqa
  • ODM 201
  • ODM-201

Drug: Degarelix
GnRH antagonist
Other Names:
  • FE200486
  • Firmagon

Drug: Goserelin
GnRH agonist
Other Name: ICI-118630

Drug: Histrelin
GnRH agonist

Drug: Leuprolide
GnRH agonist
Other Name: Leuprorelin

Radiation: Radiation Therapy
Undergo RT
Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation

Drug: Relugolix
GnRH antagonist
Other Names:
  • N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea
  • Orgovyx
  • TAK 385
  • TAK-385

Drug: Triptorelin
GnRH agonist
Other Names:
  • 6-D-Tryptophan-LH-RH
  • 6-D-Tryptophanluteinizing Hormone-releasing Factor
  • AY-25650
  • CL-118,532
  • Detryptoreline


Outcome Measures
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Primary Outcome Measures :
  1. Distant Metastasis (DM) (De-intensification study) [ Time Frame: From randomization to the detection of distant metastasis by conventional imaging, assessed up to 11 years ]
    Will be analyzed using competing-risk methods (Gooley 1999) where, in each case, death prior to occurrence of the event in question will be a competing risk.

  2. Metastasis-Free Survival (MFS) (Intensification study) [ Time Frame: From randomization until the occurrence of distant metastasis by conventional imaging or death from any cause, assessed up to 8 years ]
    MFS will be estimated by the Kaplan-Meier (1958) method and compared between the two treatment arms using a stratified log-rank test (stratified by the randomization stratification factors) at one-sided alpha level of 0.025.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: From randomization to death from any cause, assessed up to 11 years ]
    Will be estimated by the Kaplan-Meier method and compared between treatments arms by stratified log-rank test. Cox regression models will also be fit, adjusted for the stratification factors, to estimate hazard ratios, together with 95% confidence intervals.

  2. Time to Prostate Specific Antigen (PSA) failure [ Time Frame: Up to 11 years ]
    Defined as PSA > 2 ng/ml above the nadir post randomization. Will be analyzed using competing-risk methods (Gooley 1999) where, in each case, death prior to occurrence of the event in question will be a competing risk.

  3. MFS (De-intensification study) [ Time Frame: From randomization until the occurrence of distant metastasis by conventional imaging or death from any cause, assessed up to 11 years ]
    Will be estimated by the Kaplan-Meier method and compared between treatments arms by stratified log-rank test. Cox regression models will also be fit, adjusted for the stratification factors, to estimate hazard ratios, together with 95% confidence intervals.

  4. MFS including positron emission tomography (PET) imaging [ Time Frame: From randomization until the occurrence of distant metastasis by conventional and/or molecular imaging or death from any cause, assessed up to 11 years ]
    Will be estimated by the Kaplan-Meier method and compared between treatments arms by stratified log-rank test.

  5. Locoregional failure (LRF) [ Time Frame: From randomization until local or regional recurrence based upon conventional imaging or biopsy, assessed up to 11 years ]
    Will compare cumulative incidence between arms.

  6. Distant Metastasis (DM) including PET imaging [ Time Frame: From randomization to the detection of distant metastasis by conventional and/or molecular imaging, assessed up to 11 years ]
    Will be analyzed using competing-risk methods (Gooley 1999) where, in each case, death prior to occurrence of the event in question will be a competing risk.

  7. Prostate cancer-specific mortality [ Time Frame: From randomization until death from prostate cancer, assessed up to 11 years ]
    Will be analyzed using competing-risk methods (Gooley 1999) where, in each case death from causes other than prostate cancer as the competing risk.

  8. Sexual and hormonal function related quality of life [ Time Frame: Up to 5 years ]
    Measured by the Expanded Prostate Cancer Index Composite-26 (EPIC-26).

  9. Fatigue [ Time Frame: Up to 5 years ]
    Measured by the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue instrument.

  10. Cognition [ Time Frame: Up to 5 years ]
    Measured by the Functional Assessment of Chronic illness Therapy-Cognitive (FACT-Cog).

  11. Distant Metastasis (Intensification study) [ Time Frame: From randomization to the detection of distant metastasis by conventional imaging, assessed up to 11 years ]
    Will be analyzed using competing-risk methods (Gooley 1999) where, in each case, death prior to occurrence of the event in question will be a competing risk.

  12. Locoregional progression [ Time Frame: Up to 11 years ]
    Defined as defined as recurrence within the pelvis including lymph nodes below the iliac bifurcation, or prostate. Will be analyzed using competing-risk methods (Gooley 1999) where, in each case, death prior to occurrence of the event in question will be a competing risk.


Other Outcome Measures:
  1. Castrate-resistant prostate cancer (CRPC) [ Time Frame: Up to 11 years ]
    CRPC is defined as PSA increase > 25% and more than 2 ng/mL above nadir on study in conjunction with a serum testosterone (T) < 50 ng/mL, confirmed by repeat measurements at least 2 weeks apart. Will be analyzed using competing-risk methods (Gooley 1999) where, in each case, death prior to occurrence of the event in question will be a competing risk.

  2. Bowel and urinary function related quality of life [ Time Frame: Up to 5 years ]
    Measured EPIC-26. Mixed effect regression models will be fit to compare the changes over time in the domain scores. Covariates will include treatment, time, and treatment-by-time treatment interaction terms.

  3. Cardio-metabolic markers [ Time Frame: Up to 5 years ]
    Will include body mass index, lipids, blood glucose, complete blood count, comprehensive metabolic panel, and hemoglobin A1c. Mixed effect regression models will be fit to compare the changes over time in the cardio-metabolic markers between treatment groups. Covariates will include treatment, time, and treatment-by-time treatment interaction terms.

  4. PSA failure-free survival with non-castrate testosterone and no additional therapies [ Time Frame: Up to 11 years ]
  5. Locoregional failure based upon either conventional or molecular imaging [ Time Frame: Up to 11 years ]
  6. Health utilities [ Time Frame: Up to 5 years ]
    Measured by the European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L). ). The bootstrap (Efron 1980) will be performed to obtain standard errors, test for significant differences, and generate 95% confidence intervals.

  7. Time to testosterone recovery [ Time Frame: From randomization until T > 200 ng/dL, assessed up to 11 years ]
    Will be analyzed using competing-risk methods (Gooley 1999) where, in each case, death prior to occurrence of the event in question will be a competing risk. Changes in quality of life measures will be correlated with changes in testosterone levels.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of the prostate within 270 days prior to registration

  • Unfavorable intermediate risk prostate cancer, defined as having ALL the following bulleted criteria:

    • Has at least one intermediate risk factor (IRF):

      • PSA 10-20 ng/mL
      • Clinical stage T2b-c (digital rectal examination [DRE] and/or imaging) by American Joint Committee on Cancer (AJCC) 8th edition
      • Gleason score 7 (Gleason 3+4 or 4+3 [ International Society of Urological Pathology (ISUP) Grade Group 2-3])

    • Has ONE or more of the following 'unfavorable' intermediate-risk designators:

      • > 1 immature reticulocyte fraction (IRF)
      • Gleason 4+3=7 (ISUP Grade Group 3)

      • >= 50% of biopsy cores positive

        • Biopsies may include 'sextant' sampling of right/left regions of the prostate, often labeled base, mid-gland and apex. All such 'sextant' biopsy cores should be counted. Men may also undergo 'targeted' sampling of prostate lesions (guided by MRI, ultrasound or other approaches). A targeted lesion that is biopsied more than once and demonstrates cancer (regardless of number of targeted cores involved) should count as a single additional positive core sampled and positive. In cases of uncertainty, count the biopsy sampling as sextant core(s)
    • Absence of high-risk features

  • Appropriate stage for study entry based on the following diagnostic workup:

    • History/physical examination within 120 days prior to registration;
    • Negative bone imaging (M0) within 120 days prior to registration; Note: Tc-99m bone scan or sodium fluoride (NaF) positron emission tomography (PET) are allowed. Equivocal bone scan findings are allowed if plain films X-ray, computed tomography (CT) or magnetic resonance imaging (MRI) are negative for metastasis at the concerned site(s). While a negative fluciclovine, choline, or prostate specific membrane antigen (PSMA) PET may be counted as acceptable substitute for bone imaging, any suspicious findings must be confirmed and correlated with conventional imaging (Tc-99m bone scan, NaF PET, CT, X-ray, or MRI) to determine eligibility based on the latter modalities (e.g. M0 based on conventional imaging modalities)
    • Clinically negative lymph nodes (N0) as established by conventional imaging (pelvic +/- abdominal CT or MR), within 120 days prior to registration. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are =< 1.0 cm in short axis and/or if biopsy is negative.

Note: While a negative fluciclovine, choline, or prostate specific membrane antigen (PSMA) PET may be counted as acceptable substitute for pelvic imaging, any suspicious findings must be confirmed by conventional imaging (CT, MRI or biopsy). If the findings do not meet pathological criteria based on the latter modalities (e.g. node =< 10 mm in short axis, negative biopsy), the patient will still be eligible

  • Age >= 18
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 120 days prior to registration
  • Non-castrate testosterone level (> 50 ng/dL) within 120 days prior to registration
  • Absolute neutrophil >= 1,000 cells/mm^3 (within 120 days prior to registration)
  • Hemoglobin >= 8.0 g/dL, independent of transfusion and/or growth factors (within 120 days prior to registration)
  • Platelet count >= 100,000 cells/mm^3 independent of transfusion and/or growth factors (within 120 days prior to registration)

  • Creatinine clearance (CrCl) >= 30 mL/min estimated by Cockcroft-Gault equation (within 120 days prior to registration)

    • For African American patients specifically whose renal function is not considered adequate by the formula above, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) should be used for calculating the related estimated glomerular filtration rate (GFR) with a correction factor for African American race creatinine clearance for trial eligibility, where GFR >= 30 mL/min/1.73m^2 will be considered adequate
  • Total bilirubin: 1.5 =< institutional upper limit of normal (ULN) (within 120 days prior to registration) (Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin. If direct bilirubin is less than or equal to 1.5 x ULN, subject is eligible)
  • Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]): =< 2.5 x institutional ULN (within 120 days prior to registration)
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial; Note: HIV testing is not required for eligibility for this protocol

  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

    • Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B)

  • For patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

    • Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

Exclusion Criteria:

  • Previous radical surgery (prostatectomy) or any form of curative-intent ablation whether focal or whole-gland (e.g., cryosurgery, high intensity focused ultrasound [HIFU], laser thermal ablation, etc.) for prostate cancer
  • Definitive clinical or radiologic evidence of metastatic disease (M1)
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. History of or current diagnosis of hematologic malignancy is not allowed
  • Prior radiotherapy to the prostate/pelvis region that would result in overlap of radiation therapy fields
  • Previous bilateral orchiectomy
  • Previous hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate). ADT started prior to study registration is not allowed
  • Prior use of 5-alpha-reductase inhibitors is allowed, however, it must be stopped prior to enrollment on the study with at least a 30 day washout period before baseline study PSA measure and registration
  • Active testosterone replacement therapy; any replacement therapy must be stopped at least 30 days prior to registration

  • Severe, active co-morbidity defined as follows:

    • Current severe or unstable angina;
    • New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification)
    • History of any condition that in the opinion of the investigator, would preclude participation in this study
  • Inability to swallow oral pills

  • High risk features, which includes any of the following:

    • Gleason 8-10 [ISUP Grade Group 4-5]
    • PSA > 20
    • cT3-4 by digital exam OR gross extra-prostatic extension on imaging [indeterminate MRI evidence will not count and the patient will be eligible]
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05050084


Locations
Show Show 318 study locations
Sponsors and Collaborators
NRG Oncology
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Neil B Desai, MD NRG Oncology
Principal Investigator: Alejandro Berlin, MD NRG Oncology
More Information
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Layout table for additonal information
Responsible Party: NRG Oncology
ClinicalTrials.gov Identifier: NCT05050084    
Other Study ID Numbers: NRG-GU010
NCI-2021-08760 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NRG-GU010 ( Other Identifier: NRG Oncology )
NRG-GU010 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
First Posted: September 20, 2021    Key Record Dates
Last Update Posted: March 28, 2023
Last Verified: March 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Leuprolide
Goserelin
Triptorelin Pamoate
Flutamide
Bicalutamide
Tryptophan
Buserelin
Hormones
Relugolix
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Contraceptive Agents, Hormonal
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs