Trial Outcomes & Findings for Phase II Study of Docetaxel Before Degarelix in Patients With Newly Diagnosed Metastatic Prostate Cancer. (NCT NCT03069937)

Last Updated: 2025-10-15

Results Overview

PSA complete response is defined as PSA level less than or equal to 0.2 ng/ml for two consecutive measurements at least three weeks apart. Date of complete response will be defined as the date of first recorded value less than 0.2 ng/ml. PSA progression will be defined as \> 25% increase from the PSA nadir (lowest PSA value recorded since trial enrollment) and \> 2 ng/dl above the nadir. Two consecutive increases must be recorded at least three weeks apart. Date of PSA progression will be defined as the first recorded PSA value that is a \> 25% increase from the PSA nadir and \> 2 ng/dl above the nadir.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

52 participants

Primary outcome timeframe

10 months

Results posted on

2025-10-15

Participant Flow

Of the 52 subjects in the study, 51 were evaluable for the primary endpoint. The one unevaluable subject got a second primary malignancy noted after registration but prior to start of study.

Participant milestones

Participant milestones
Measure	Docetaxel + Degarelix Docetaxel (TAXOTERE) will be given for up to 6 cycles every 21 days. During the 5th and 6th cycles, degarelix (Firmagon) will be administered on Cycle 5 day 1 and cycle 6 day 8. After cycle 6, degarelix will continue to be given every 28 days for a 5 more doses, for a total of 7 doses. Docetaxel: The docetaxel dose is a 75mg/m2 intravenous (given through the vein) injection. Degarelix: Degarelix will be given as a subcutaneous (given under the skin) injection in the abdomen. The first dose will be a 240mg dose; all other doses will be 80 mg.
Overall Study STARTED	52
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Docetaxel + Degarelix Docetaxel (TAXOTERE) will be given for up to 6 cycles every 21 days. During the 5th and 6th cycles, degarelix (Firmagon) will be administered on Cycle 5 day 1 and cycle 6 day 8. After cycle 6, degarelix will continue to be given every 28 days for a 5 more doses, for a total of 7 doses. Docetaxel: The docetaxel dose is a 75mg/m2 intravenous (given through the vein) injection. Degarelix: Degarelix will be given as a subcutaneous (given under the skin) injection in the abdomen. The first dose will be a 240mg dose; all other doses will be 80 mg.
Overall Study Second primary malignancy noted	1

Baseline Characteristics

Phase II Study of Docetaxel Before Degarelix in Patients With Newly Diagnosed Metastatic Prostate Cancer.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Docetaxel + Degarelix n=52 Participants Docetaxel (TAXOTERE) will be given for up to 6 cycles every 21 days. During the 5th and 6th cycles, degarelix (Firmagon) will be administered on Cycle 5 day 1 and cycle 6 day 8. After cycle 6, degarelix will continue to be given every 28 days for a 5 more doses, for a total of 7 doses. Docetaxel: The docetaxel dose is a 75mg/m2 intravenous (given through the vein) injection. Degarelix: Degarelix will be given as a subcutaneous (given under the skin) injection in the abdomen. The first dose will be a 240mg dose; all other doses will be 80 mg.
Age, Continuous	67.5 years STANDARD_DEVIATION 7.01 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 months

Population: The Primary endpoint for this trial is a binary indicator of PSA less than or equal to 0.2 ng/mL at 10 months (40 weeks) on study. This also represents 7 months (28 weeks) on androgen deprivation therapy with Degarelix

Outcome measures

Outcome measures
Measure	Docetaxel + Degarelix n=51 Participants Docetaxel (TAXOTERE) will be given for up to 6 cycles every 21 days. During the 5th and 6th cycles, degarelix (Firmagon) will be administered on Cycle 5 day 1 and cycle 6 day 8. After cycle 6, degarelix will continue to be given every 28 days for a 5 more doses, for a total of 7 doses. Docetaxel: The docetaxel dose is a 75mg/m2 intravenous (given through the vein) injection. Degarelix: Degarelix will be given as a subcutaneous (given under the skin) injection in the abdomen. The first dose will be a 240mg dose; all other doses will be 80 mg.
PSA Response at 10 Months	15 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Undetectable PSA at 6 months is a binary indicator for each patient of PSA less than or equal to 0.2 ng/dl at 6 months (24 weeks) on study.

Outcome measures

Outcome measures
Measure	Docetaxel + Degarelix n=51 Participants Docetaxel (TAXOTERE) will be given for up to 6 cycles every 21 days. During the 5th and 6th cycles, degarelix (Firmagon) will be administered on Cycle 5 day 1 and cycle 6 day 8. After cycle 6, degarelix will continue to be given every 28 days for a 5 more doses, for a total of 7 doses. Docetaxel: The docetaxel dose is a 75mg/m2 intravenous (given through the vein) injection. Degarelix: Degarelix will be given as a subcutaneous (given under the skin) injection in the abdomen. The first dose will be a 240mg dose; all other doses will be 80 mg.
PSA Response at 6 Months	14 Participants

SECONDARY outcome

Timeframe: Up to 12 weeks (first 4 cycles of docetaxel)

Population: Total possibly and probably related events that occur in the first 4 cycles Docetaxel

This measure reports the number of Grade 3 and 4 adverse events that were possibly or probably related to docetaxel and occurred during the first 4 cycles (approximately 12 weeks) of treatment

Outcome measures

Outcome measures
Measure	Docetaxel + Degarelix n=273 adverse events Docetaxel (TAXOTERE) will be given for up to 6 cycles every 21 days. During the 5th and 6th cycles, degarelix (Firmagon) will be administered on Cycle 5 day 1 and cycle 6 day 8. After cycle 6, degarelix will continue to be given every 28 days for a 5 more doses, for a total of 7 doses. Docetaxel: The docetaxel dose is a 75mg/m2 intravenous (given through the vein) injection. Degarelix: Degarelix will be given as a subcutaneous (given under the skin) injection in the abdomen. The first dose will be a 240mg dose; all other doses will be 80 mg.
Number of Grade 3 and 4 Adverse Events Related to Docetaxel During First 4 Cycles	6 adverse events

SECONDARY outcome

Timeframe: 12 weeks

PSA progression will be defined as \> 25% increase from the PSA nadir (lowest PSA value recorded since trial enrollment) and \> 2 ng/dl above the nadir. Two consecutive increases must be recorded at least two weeks apart. Date of PSA progression will be defined as the first recorded PSA value that is a \> 25% increase from the PSA nadir and \> 2 ng/dl above the nadir. PSA progression will not be established during the first 12 weeks of therapy (4 cycles of docetaxel) as defined by PCWG2 criteria. Thus subjects with no PSA decline from baseline during therapy will have date of PSA progression defined as first PSA value after 12 weeks that is a \> 25% increase from the PSA nadir and \> 2 ng/dl above the nadir.

Outcome measures

Outcome measures
Measure	Docetaxel + Degarelix n=51 Participants Docetaxel (TAXOTERE) will be given for up to 6 cycles every 21 days. During the 5th and 6th cycles, degarelix (Firmagon) will be administered on Cycle 5 day 1 and cycle 6 day 8. After cycle 6, degarelix will continue to be given every 28 days for a 5 more doses, for a total of 7 doses. Docetaxel: The docetaxel dose is a 75mg/m2 intravenous (given through the vein) injection. Degarelix: Degarelix will be given as a subcutaneous (given under the skin) injection in the abdomen. The first dose will be a 240mg dose; all other doses will be 80 mg.
Frequency of Disease Progression at 12 Weeks Using PSA	12 Participants

SECONDARY outcome

Timeframe: 12 weeks

PSA complete response is defined as PSA level less than or equal to 0.2 ng/ml for two consecutive measurements at least two weeks apart. Date of complete response will be defined as the date of first recorded value less than 0.2 ng/ml. PSA Partial Response is defined as a decline of PSA from trial baseline of \> 50% for two consecutive measurements at least two weeks apart. Date of partial response will be defined as the date of first recorded decline of \> 50% baseline. PSA progression is defined in outcome 4.

Outcome measures

Outcome measures
Measure	Docetaxel + Degarelix n=51 Participants Docetaxel (TAXOTERE) will be given for up to 6 cycles every 21 days. During the 5th and 6th cycles, degarelix (Firmagon) will be administered on Cycle 5 day 1 and cycle 6 day 8. After cycle 6, degarelix will continue to be given every 28 days for a 5 more doses, for a total of 7 doses. Docetaxel: The docetaxel dose is a 75mg/m2 intravenous (given through the vein) injection. Degarelix: Degarelix will be given as a subcutaneous (given under the skin) injection in the abdomen. The first dose will be a 240mg dose; all other doses will be 80 mg.
PSA Response at 12 Weeks PSA complete response	1 Participants
PSA Response at 12 Weeks PSA partial response	20 Participants

SECONDARY outcome

Timeframe: From initiation of Degarelix until disease progression or end of follow-up (up to 34 months)

Population: evaluable subjects who were administered Degarelix

This will be defined as the time from initial Degarelix injection to the time of disease progression (clinical, radiographic or PSA. Determination of castration resistant disease status will require disease progression and a measured serum testosterone level less than 50 ng/dl.

Outcome measures

Outcome measures
Measure	Docetaxel + Degarelix n=40 Participants Docetaxel (TAXOTERE) will be given for up to 6 cycles every 21 days. During the 5th and 6th cycles, degarelix (Firmagon) will be administered on Cycle 5 day 1 and cycle 6 day 8. After cycle 6, degarelix will continue to be given every 28 days for a 5 more doses, for a total of 7 doses. Docetaxel: The docetaxel dose is a 75mg/m2 intravenous (given through the vein) injection. Degarelix: Degarelix will be given as a subcutaneous (given under the skin) injection in the abdomen. The first dose will be a 240mg dose; all other doses will be 80 mg.
Time to Development of Castration Resistance After Initiation With ADT	16.1 months Interval 9.73 to 23.5

SECONDARY outcome

Timeframe: 34 months

Population: progressions from day 1 of Docetaxel

Progression free Survival (PFS) will be defined as the duration of time from start of study treatment to time of disease progression or death, whichever comes first.

Outcome measures

Outcome measures
Measure	Docetaxel + Degarelix n=41 Participants Docetaxel (TAXOTERE) will be given for up to 6 cycles every 21 days. During the 5th and 6th cycles, degarelix (Firmagon) will be administered on Cycle 5 day 1 and cycle 6 day 8. After cycle 6, degarelix will continue to be given every 28 days for a 5 more doses, for a total of 7 doses. Docetaxel: The docetaxel dose is a 75mg/m2 intravenous (given through the vein) injection. Degarelix: Degarelix will be given as a subcutaneous (given under the skin) injection in the abdomen. The first dose will be a 240mg dose; all other doses will be 80 mg.
Progression Free Survival	15.9 months Interval 11.4 to 24.2

SECONDARY outcome

Timeframe: From trial enrollment until death or end of follow-up (up to 52.4 months)

Population: subjects who died from any cause

OS is defined as the time interval from trial enrollment to death due to any cause. Survival times will be censored for patients lost to follow-up or still alive at the trial's termination.

Outcome measures

Outcome measures
Measure	Docetaxel + Degarelix n=28 Participants Docetaxel (TAXOTERE) will be given for up to 6 cycles every 21 days. During the 5th and 6th cycles, degarelix (Firmagon) will be administered on Cycle 5 day 1 and cycle 6 day 8. After cycle 6, degarelix will continue to be given every 28 days for a 5 more doses, for a total of 7 doses. Docetaxel: The docetaxel dose is a 75mg/m2 intravenous (given through the vein) injection. Degarelix: Degarelix will be given as a subcutaneous (given under the skin) injection in the abdomen. The first dose will be a 240mg dose; all other doses will be 80 mg.
Overall Survival (OS)	52.4 months Interval 46.9 to 57.9

Adverse Events

Docetaxel + Degarelix

Serious events: 4 serious events

Other events: 49 other events

Deaths: 28 deaths

Serious adverse events

Serious adverse events
Measure	Docetaxel + Degarelix n=51 participants at risk Docetaxel (TAXOTERE) will be given for up to 6 cycles every 21 days. During the 5th and 6th cycles, degarelix (Firmagon) will be administered on Cycle 5 day 1 and cycle 6 day 8. After cycle 6, degarelix will continue to be given every 28 days for a 5 more doses, for a total of 7 doses. Docetaxel: The docetaxel dose is a 75mg/m2 intravenous (given through the vein) injection. Degarelix: Degarelix will be given as a subcutaneous (given under the skin) injection in the abdomen. The first dose will be a 240mg dose; all other doses will be 80 mg.
Blood and lymphatic system disorders febrile neutropenia	2.0% 1/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Musculoskeletal and connective tissue disorders myositis	2.0% 1/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Infections and infestations Anorectal infection	2.0% 1/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Infections and infestations Lung infection	2.0% 1/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.

Other adverse events

Other adverse events
Measure	Docetaxel + Degarelix n=51 participants at risk Docetaxel (TAXOTERE) will be given for up to 6 cycles every 21 days. During the 5th and 6th cycles, degarelix (Firmagon) will be administered on Cycle 5 day 1 and cycle 6 day 8. After cycle 6, degarelix will continue to be given every 28 days for a 5 more doses, for a total of 7 doses. Docetaxel: The docetaxel dose is a 75mg/m2 intravenous (given through the vein) injection. Degarelix: Degarelix will be given as a subcutaneous (given under the skin) injection in the abdomen. The first dose will be a 240mg dose; all other doses will be 80 mg.
General disorders Fatigue	76.5% 39/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Vascular disorders Hot flashes	56.9% 29/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Skin and subcutaneous tissue disorders Alopecia	51.0% 26/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Gastrointestinal disorders Nausea	35.3% 18/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
General disorders Edema limbs	33.3% 17/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Gastrointestinal disorders Constipation	31.4% 16/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Nervous system disorders Dysgeusia	31.4% 16/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Skin and subcutaneous tissue disorders Nail discoloration	31.4% 16/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
General disorders Injection site reaction	27.5% 14/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Eye disorders Watering eyes	21.6% 11/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Gastrointestinal disorders Diarrhea	21.6% 11/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Musculoskeletal and connective tissue disorders Bone pain	15.7% 8/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Musculoskeletal and connective tissue disorders Myalgia	15.7% 8/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Vascular disorders Hypertension	13.7% 7/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Musculoskeletal and connective tissue disorders Back pain	11.8% 6/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Nervous system disorders Dizziness	11.8% 6/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Nervous system disorders Peripheral sensory neuropathy	11.8% 6/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
General disorders Pain	9.8% 5/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Investigations Weight loss	9.8% 5/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Musculoskeletal and connective tissue disorders Arthralgia	9.8% 5/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Skin and subcutaneous tissue disorders Rash maculo papular	9.8% 5/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
General disorders Flu like symptoms	7.8% 4/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Metabolism and nutrition disorders Anorexia	7.8% 4/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Psychiatric disorders Insomnia	7.8% 4/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Vascular disorders Hypotension	7.8% 4/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Nervous system disorders Peripheral motor neuropathy	5.9% 3/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Renal and urinary disorders Cystitis noninfective	5.9% 3/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Infections and infestations Nail infection	5.9% 3/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Gastrointestinal disorders Abdominal pain	5.9% 3/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Gastrointestinal disorders Dyspepsia	5.9% 3/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Musculoskeletal and connective tissue disorders Chest wall pain	5.9% 3/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Nervous system disorders Headache	5.9% 3/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Nervous system disorders Paresthesia	5.9% 3/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Renal and urinary disorders Hematuria	5.9% 3/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Renal and urinary disorders Urinary retention	5.9% 3/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Respiratory, thoracic and mediastinal disorders Cough	5.9% 3/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.9% 3/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.
Skin and subcutaneous tissue disorders Rash acneiform	5.9% 3/51 • Adverse events were assessed up to 10 months. All-cause mortality was assessed up to 52.4 months.

Additional Information

Principal Investigator

Medical University of South Carolina

Phone: 843-792-4271

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place