Current partner codePEPTIDESDE
NCT03009981·Phase 3·INTERVENTIONAL

A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer

Status

Completed

Phase

Phase 3

Enrollment

504

Locations

69

Results

Not posted

Publications

8

Study summary

What the protocol is testing.

This is a randomized, open-label, three-arm, phase 3 study in men with biochemically recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry.

Full detailed description

Patients will be stratified by PSA doubling time (\< 3 months vs. 3-9 months) and randomized in 1:1:1 fashion to one of three treatment arms: (1) Control arm consisting of LHRH analogue monotherapy (degarelix or leuprolide), (2) Experimental arm consisting of apalutamide in combination with LHRH analogue, and (3) Experimental arm consisting of apalutamide, abiraterone acetate + prednisone, and LHRH analogue. Patients will be treated for a maximum duration of 52 weeks and then enter follow up phase until the time of PSA progression, development of metastasis, or patient withdrawal from study, whichever occurs first. Patients with PSA progression will be followed long term until the development of castration resistance, first metastasis, and death. The primary endpoint of the study is PSA progression-free survival in the intent-to-treat patient population. PSA progression during the 52-week treatment period is defined as a rising PSA confirmed on repeat measurement, and at least 25% and 2 ng/mL above nadir or baseline, whichever is lower. PSA progression during follow up defined as PSA \> 0.2 ng/mL confirmed by repeat measurement at least 2 weeks later. Secondary study endpoints include PSA progression-free survival in testosterone-evaluable population, 36-month PSA progression-free survival rate in both intent-to-treat and testosterone-evaluable populations, time to testosterone recovery, time to castration resistance, metastasis-free survival, quality of life, and safety. Each experimental arm will be compared against the control arm in pair-wise fashion. The study is not powered to detect differences in primary or secondary endpoints between the two experimental arms.

Interventions

Treatment arms and agents.

DRUG

Apalutamide

Take apalutamide 240 mg (four 60 mg tablets) orally once daily, starting on C1D1 and continuing throughout 52-week treatment period.

DRUG

LHRH Analogue

Patients will receive a LHRH analogue therapy of either Degarelix OR Leuprolide with bicalutamide. Degarelix: Patients will receive subcutaneous injections every 28 days (+/- 3 days). Patients will receive a loading dose of 240 mg (two 120 mg injections) on C1D1, followed by maintenance dose of 80 mg on Day 1 of subsequent cycles. Leuprolide: Patients treated with leuprolide will receive a 7.5 mg IM injection on C1D1. Patients in arm A ONLY will take this in combination with bicalutamide 50 mg orally once daily starting on C1D1 and continuing for 28 days through completion of cycle 1. Starting on C2D1, patients will continue on one of the following two treatments at investigator discretion: 1. Leuprolide 7.5 mg IM injection on Day 1 of subsequent cycles without concurrent bicalutamide. OR: 2. Leuprolide 22.5 mg IM injection at the following visits without concurrent bicalutamide: C2D1, C5D1, C8D1, and C11D1.

DRUG

Abiraterone Acetate

Take abiraterone acetate 1000 mg (four 250 mg tablets) orally once daily, starting on C1D1 and continuing throughout 52-week treatment period.

DRUG

Prednisone

Take two prednisone 5 mg tablets daily, starting on C1D1 and continuing throughout the 52-week treatment period. Following completion of treatment period, patients will taper off prednisone per institutional guidelines. Suggested tapering plan: prednisone 5 mg daily for 7 days, then 2.5 mg daily for 7 days before discontinuing.

Timeline

From registration to results.

  1. First posted

    Jan 4, 2017

  2. Study start

    Mar 6, 2017

  3. Primary completion

    Jun 25, 2025

  4. Study completion

    Jun 25, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Dec 18, 2025

Outcomes

What the study measures.

Primary outcomes

PSA progression-free survival in the intent-to-treat population

Time frame · 36 months

To compare PSA progression-free survival in each of the experimental arms (LHRH analogue + apalutamide; LHRH analogue + apalutamide +abiraterone acetate) versus the control arm (LHRH analogue) among all randomized patients (intent-to-treat population).

Secondary outcomes

PSA progression-free survival in the testosterone-evaluable population

Time frame · 36 months

Compare PSA progression-free survival in testosterone-evaluable population in each experimental arm versus the control arm. Testosterone-evaluable population includes all patients who achieve serum testosterone recovery to \> 50 ng/dL with subsequent PSA measurements sufficient for evaluation

PSA progression-free survival in both the intent-to-treat and testosterone-evaluable populations

Time frame · 36 months

To compare the 36-month PSA progression-free survival rate in each experimental arm versus the control arm in both the intent-to-treat and testosterone-evaluable populations.

Serum testosterone

Time frame · 12 months

To compare the time to recovery of serum testosterone to greater than 50 ng/dL in each experimental arm versus the control arm.

Time to castration resistance

Time frame · 6 years

To compare the time to castration resistance in each experimental arm versus the control arm.

Metastasis-Free Survival

Time frame · 6 years

To compare metastasis-free survival in each experimental arm versus the control arm.

Overall Survival

Time frame · 6 years

To compare overall survival in each experimental arm versus the control arm.

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time frame · 6 years

To characterize the safety profile in each treatment arm

Quality of life Expanded Prostate Cancer Index Composite (EPIC)

Time frame · 72 months

Expanded Prostate Cancer Index Composite (EPIC)

Quality of life Hot Flash Daily Interference Scale (HFRDIS)

Time frame · 72 months

Hot Flash Daily Interference Scale (HFRDIS)

Quality of life EQ-5D-5L

Time frame · 72 months

EQ-5D-5L

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
MALE
Healthy volunteers
No

Inclusion Criteria: * Histologically confirmed prostate adenocarcinoma * Prior radical prostatectomy * Biochemically recurrent prostate cancer with PSA doubling time ≤ 9 months at the time of study entry. Calculation of PSA doubling time should include the use of all available PSA values obtained within past 6-12 months prior to randomization, with a minimum of 3 values separated by at least 2 weeks apart. PSA values obtained prior to therapeutic interventions (e.g. salvage radiation) will be excluded. PSA doubling time to be estimated using Memorial Sloan Kettering Cancer Center online calculator (https://www.mskcc.org/nomograms/prostate/psa-doubling-time) * Prior adjuvant or salvage radiation or not a candidate for radiation based upon clinical assessment of disease characteristics and patient co-morbidities. * Screening PSA \> 0.5 ng/mL * No definitive evidence of metastases on screening CT or MRI of abdomen/pelvis and radionuclide whole body bone scan per the judgment of the investigator. Abdominal and/or pelvic lymph nodes measuring 2 cm or less in short axis diameter are allowed. Lesions identified on other imaging modalities (e.g. PSMA or choline PET) that are not visualized on CT and/or MRI or radionuclide bone scan are allowed. Equivocal lesions on bone scan should be followed up with additional imaging as clinically indicated. * Screening serum testosterone \> 150 ng/dL * Eastern Cooperative Oncology Group (ECOG) Performance Status grade 0 or 1 * Age ≥ 18 years * Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to cycle 1 day 1 * Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug. * Adequate organ function as defined by the following laboratory values at screening: * Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase \[SGOT\]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase \[SGPT\]) \< 2.5 x upper limit of normal (ULN) * Total serum bilirubin ≤1.5 x ULN. In subjects with Gilbert's syndrome, if total bilirubin is \>1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject may be eligible) * Serum potassium ≥ 3.5 mmol/L. Supplementation and re-screening is allowed. * Estimated creatinine clearance \> 45 ml/min using Cockroft-Gault equation * Platelets ≥ 100,000/microliter independent of transfusion and/or growth factors within 3 months prior to randomization * Hemoglobin ≥ 9.0 g/dL independent of transfusion and/or growth factors within 3 months prior to randomization * Serum albumin ≥ 3.0 g/dL Exclusion Criteria: * Prior androgen deprivation therapy and/or first generation anti-androgen (e.g. bicalutamide, nilutamide, flutamide) for biochemically recurrent prostate cancer. Prior ADT and/or first generation anti-androgen in the (neo)adjuvant and/or salvage setting before, during, and/or following radiation or surgery is allowed provided last effective dose of ADT and/or first-generation anti-androgen is \> 9 months prior to date of randomization and total duration of prior therapy is ≤ 36 months. * Prior treatment with CYP17 inhibitor (e.g. ketoconazole, abiraterone acetate, galeterone) or second generation androgen receptor antagonist including apalutamide or enzalutamide * Prior chemotherapy for prostate cancer except if administered in neoadjuvant or adjuvant setting * Use of 5-alpha reductase inhibitor within 42 days prior to cycle 1 day 1 * Use of investigational agent within 28 days prior to randomization * Use of other prohibited medications within 7 days prior to cycle 1 day 1 on study (Arms B and C only) * Prior bilateral orchiectomy * Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy) * Uncontrolled hypertension * Gastrointestinal disorder affecting absorption or the ability to swallow tablets * Baseline severe hepatic impairment (Child-Pugh Class B \& C) * Intercurrent illness that is not controlled such as active infection, psychiatric illness/social situations that would limit compliance with study requirements * Any chronic medical condition requiring a higher dose of corticosteroid than equivalent of 5 mg prednisone/prednisolone once daily

Study locations

69 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

The Mayo Clinic - Phoenix

Phoenix, Arizona, United States

Sharp Memorial Hospital

Chula Vista, California, United States

City of Hope National Medical Center

Duarte, California, United States

Palo Alto Medical Foundation

Fremont, California, United States

VA Central California Health Care System

Fresno, California, United States

Sharp Memorial Hospital

La Mesa, California, United States

Palo Alto Medical Foundation

Mountain View, California, United States

Palo Alto Medical Foundation

Palo Alto, California, United States

University of California San Diego - Moores Cancer Center

San Diego, California, United States

Sharp Memorial Hospital

San Diego, California, United States

University of California San Francisco

San Francisco, California, United States

Palo Alto Medical Foundation

Santa Cruz, California, United States

Adventist Health St. Helena/St. Helena Hospital/Martin O'Neil Cancer Center

St. Helena, California, United States

Palo Alto Medical Foundation

Sunnyvale, California, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Pali Momi Medical Center

‘Aiea, Hawaii, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Northshore University Health System

Evanston, Illinois, United States

Loyola University

Maywood, Illinois, United States

Quincy Medical Group

Quincy, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Publications

Results and literature.

PMID 25559415Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5.PMID 14665878Zietman AL, Chung CS, Coen JJ, Shipley WU. 10-year outcome for men with localized prostate cancer treated with external radiation therapy: results of a cohort study. J Urol. 2004 Jan;171(1):210-4. doi: 10.1097/01.ju.0000100980.13364.a6.PMID 26996659Humphrey PA, Moch H, Cubilla AL, Ulbright TM, Reuter VE. The 2016 WHO Classification of Tumours of the Urinary System and Male Genital Organs-Part B: Prostate and Bladder Tumours. Eur Urol. 2016 Jul;70(1):106-119. doi: 10.1016/j.eururo.2016.02.028. Epub 2016 Mar 17.PMID 15681527Zelefsky MJ, Ben-Porat L, Scher HI, Chan HM, Fearn PA, Fuks ZY, Leibel SA, Venkatraman ES. Outcome predictors for the increasing PSA state after definitive external-beam radiotherapy for prostate cancer. J Clin Oncol. 2005 Feb 1;23(4):826-31. doi: 10.1200/JCO.2005.02.111.PMID 25563505Qu Y, Dai B, Ye D, Kong Y, Chang K, Jia Z, Yang X, Zhang H, Zhu Y, Shi G. Constitutively active AR-V7 plays an essential role in the development and progression of castration-resistant prostate cancer. Sci Rep. 2015 Jan 7;5:7654. doi: 10.1038/srep07654.PMID 20847477Gershon RC, Rothrock N, Hanrahan R, Bass M, Cella D. The use of PROMIS and assessment center to deliver patient-reported outcome measures in clinical research. J Appl Meas. 2010;11(3):304-14.PMID 38421252Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part III: Salvage Therapy After Radiotherapy or Focal Therapy, Pelvic Nodal Recurrence and Oligometastasis, and Future Directions. J Urol. 2024 Apr;211(4):526-532. doi: 10.1097/JU.0000000000003890. Epub 2024 Feb 29.PMID 38261983Aggarwal R, Heller G, Hillman DW, Xiao H, Picus J, Taplin ME, Dorff T, Appleman L, Weckstein D, Patnaik A, Bryce A, Shevrin D, Mohler J, Anderson D, Rao A, Tagawa S, Tan A, Halabi S, Dooley K, O'Brien P, Chen R, Ryan CJ, Eggener SE, Morris MJ; EORTC-55994 Study Group. PRESTO: A Phase III, Open-Label Study of Intensification of Androgen Blockade in Patients With High-Risk Biochemically Relapsed Castration-Sensitive Prostate Cancer (AFT-19). J Clin Oncol. 2024 Apr 1;42(10):1114-1123. doi: 10.1200/JCO.23.01157. Epub 2024 Jan 23.

Primary links

Continue at the source.

Related trials

More studies on Degarelix.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.