Combined pCR or MRD Rate [Part 1]
| Group | Value (Participants) |
|---|---|
| Arm 1A: AAPL Neoadjuvant Therapy (Part 1) | 12 |
| Arm 1B: APL Neoadjuvant Therapy (Part 1) | 12 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy
NCT0290336819 Oct 2016 to 10 Jul 2024
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This multicenter randomized phase II trial investigates the impact of intense androgen deprivation on radical prostatectomy (RP) pathologic response and radiographic and tissue biomarkers in localized prostate cancer (NCT02903368).
Experimental
Arm 1A: AAPL Neoadjuvant Therapy [Part 1]
Eligible Participants will be randomized to receive: AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months Pts x weeks to RP
Experimental
Arm 1B: APL Neoadjuvant Therapy [Part 1]
Eligible Participants will be randomized to receive: APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
Experimental
Arm 2A: AAPL Adjuvant Therapy [Part 2]
Eligible Participants will be randomized to receive: AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 12 months
No intervention
Arm 2B: Observation [Part 2]
Outcomes the sponsor listed as primary.
Combined pCR or MRD Rate [Part 1]
Time frame · Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.
Pathological response, defined as achieving either pCR or MRD at radical prostatectomy (RP). Pathological Complete Response (pCR) is defined as the absence of morphologically identifiable carcinoma in the RP specimen. MRD will be defined as residual tumor in the RP specimen measuring ≤ 5 mm.
Biochemical Progression Free Survival (bPFS) Rate at 3 Years Post RP [Part 2]
Time frame · At 3 years post RP
3-year bPFS rate is defined as the probability of biochemical progression free and survival at 3 years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event is considered to be biochemical progression (defined as a confirmed PSA ≥ 0.2 ng/mL), local, regional, or distant metastatic disease on CT/MRI or bone scan, or receipt of post-operative systemic therapy or radiotherapy for rising PSA, or death from any cause. Participants who are lost to follow-up before the 3-year mark are censored at date last disease evaluation.
Rate of pCR at RP (Part 1)
Time frame · Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.
Pathological Complete Response (pCR) is defined as the absence of morphologically identifiable carcinoma in the RP specimen at radical prostatectomy (RP).
Median of Residual Cancer Burden (RCB) at RP (Part 1)
Time frame · Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.
RCB was calculated as "tumor volume (cm\^3) X % cellularity". RCB was analyzed as a continuous score (with median and range) instead of a categorical variable based on the percentile cutoff point, at the time of radical prostatectomy (RP).
Frequency of Presenting Cribriform at RP (Part 1)
Time frame · Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.
Presence or cribriform was evaluated by central pathology review of specimens at radical prostatectomy (RP).
Frequency of Presenting Intraductal Carcinoma at RP (Part 1)
Time frame · Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.
Intraductal carcinoma was evaluated by central pathology review of specimens at Radical Prostatectomy (RP).
Frequency of Positive Surgical Margins at RP (Part 1)
Time frame · Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.
Pathologic specimens were centrally reviewed and counted for positive surgical margins at the time of Radical Prostatectomy (RP).
Percent of Participants With Nadir PSA < 0.2 ng/mL Prior to RP (Part 1)
Time frame · Assessed on day 1 of each cycle (1 cycle=28 +/- 2 days), up to 6 months from the initiation of neoadjuvant therapy.
Prostate specific antigen (PSA) was measured on day 1 of each cycle during the neoadjuvant therapy. PSA nadir was defined as the lowest PSA value prior to Radical Prostatectomy (RP). Number and percent of participants with nadir PSA \< 0.2 ng/mL were reported.
Frequency of Presenting Intra-operative Complications Following RP (Part 1)
Time frame · Assessed post-RP, at 6 months from the initiation of neoadjuvant therapy.
Intra-operative complications were collected via questionnaire following Radical Prostatectomy.
Biochemical Progression Free Survival (bPFS) Rate at 2 Years Post RP [Part 2]
Time frame · At 2 years post RP
2-year bPFS rate is defined as the probability of biochemical progression free and survival at 2 years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event is considered to be biochemical progression (defined as a confirmed PSA ≥ 0.2 ng/mL), local, regional, or distant metastatic disease on CT/MRI or bone scan, or receipt of post-operative systemic therapy or radiotherapy for rising PSA, or death from any cause. Participants who are lost to follow-up before the 2-year mark are censored at date of last disease evaluation.
Biochemical Progression Free Survival (bPFS) Rate at 4 Years Post RP [Part 2]
Time frame · At 4 years post RP
4-year bPFS rate is defined as the probability of biochemical progression free and survival at 4 years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event is considered to be biochemical progression (defined as a confirmed PSA ≥ 0.2 ng/mL), local, regional, or distant metastatic disease on CT/MRI or bone scan, or receipt of post-operative systemic therapy or radiotherapy for rising PSA, or death from any cause. Participants who are lost to follow-up before the 4-year mark are censored at date of last disease evaluation.
Rate of Freedom From Further Anti-cancer Therapy at 2-years Post RP (Part 2)
Time frame · At 2-years post RP
Defined as the probability of freedom from further anti-cancer therapy at 2-years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event includes initiation of anti-cancer therapy (radiation therapy, ADT, or other therapies) for rising PSAs and/or clinical progression. Participants who are lost to follow-up before the 2-year mark are censored at date of last follow-up.
Rate of Freedom From Further Anti-cancer Therapy at 3-years Post RP (Part 2)
Time frame · At 3 years post RP
Defined as the probability of freedom from further anti-cancer therapy at 3-years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event includes initiation of anti-cancer therapy (radiation therapy, ADT, or other therapies) for rising PSAs and/or clinical progression. Participants who are lost to follow-up before the 3-year mark are censored at date of last follow-up.
Rate of Freedom From Further Anti-cancer Therapy at 4-years Post RP (Part 2)
Time frame · At 4-years post RP
Defined as the probability of freedom from further anti-cancer therapy at 4-years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event includes initiation of anti-cancer therapy (radiation therapy, ADT, or other therapies) for rising PSAs and/or clinical progression. Participants who are lost to follow-up before the 4-year mark are censored at date of last follow-up.
Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 6-months Post-RP (Part 2)
Time frame · At 6-months post-RP
The QOL will be measured using the Expanded Prostate Cancer Index Composite 26 (EPIC-26). For part 2, the questionnaires will be administered at 6 months, 12 months, and 24 months post RP. Resulting domain scores for EPIC-26 (urinary incontinence, urinary obstruction, sexual, bowel, hormonal/vitality) is on a 0-100 scale, with higher values representing a more favorable health-related QOL.
Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 12-months Post-RP (Part 2)
Time frame · At 12-months post-RP
The QOL will be measured using the Expanded Prostate Cancer Index Composite 26 (EPIC-26). For part 2, the questionnaires will be administered at 6 months, 12 months, and 24 months post RP. Resulting domain scores for EPIC-26 (urinary incontinence, urinary obstruction, sexual, bowel, hormonal/vitality) is on a 0-100 scale, with higher values representing a more favorable health-related QOL.
Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 24-months Post-RP (Part 2)
Time frame · At 24-months post-RP
The QOL will be measured using the Expanded Prostate Cancer Index Composite 26 (EPIC-26). For part 2, the questionnaires will be administered at 6 months, 12 months, and 24 months post RP. Resulting domain scores for EPIC-26 (urinary incontinence, urinary obstruction, sexual, bowel, hormonal/vitality) is on a 0-100 scale, with higher values representing a more favorable health-related QOL.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| Arm 1A: AAPL Neoadjuvant Therapy (Part 1) | 12 |
| Arm 1B: APL Neoadjuvant Therapy (Part 1) | 12 |
| Group | Value (percentage of subjects) |
|---|---|
| Arm 2A: AAPL Adjuvant Therapy (Part 2) | 81 |
| Arm 2B: Observation (Part 2) | 72 |
| Group | Value (Participants) |
|---|---|
| Arm 1A: AAPL Neoadjuvant Therapy (Part 1) | 7 |
| Arm 1B: APL Neoadjuvant Therapy (Part 1) | 6 |
| Group | Value ((cm^3) * %) |
|---|---|
| Arm 1A: AAPL Neoadjuvant Therapy (Part 1) | 0.023 |
| Arm 1B: APL Neoadjuvant Therapy (Part 1) | 0.075 |
| Group | Value (Participants) |
|---|---|
| Arm 1A: AAPL Neoadjuvant Therapy (Part 1) | 1 |
| Arm 1B: APL Neoadjuvant Therapy (Part 1) | 0 |
| Group | Value (Participants) |
|---|---|
| Arm 1A: AAPL Neoadjuvant Therapy (Part 1) | 15 |
| Arm 1B: APL Neoadjuvant Therapy (Part 1) | 19 |
| Group | Value (Participants) |
|---|---|
| Arm 1A: AAPL Neoadjuvant Therapy (Part 1) | 4 |
| Arm 1B: APL Neoadjuvant Therapy (Part 1) | 7 |
| Group | Value (Participants) |
|---|---|
| Arm 1A: AAPL Neoadjuvant Therapy (Part 1) | 55 |
| Arm 1B: APL Neoadjuvant Therapy (Part 1) | 58 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Arm 1A: AAPL Neoadjuvant Therapy (Part 1)Eligible Participants will be randomized to receive: AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months | 0 / 59 | 8 / 59 | 59 / 59 |
| Arm 1B: APL Neoadjuvant Therapy (Part 1)Eligible Participants will be randomized to receive: APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months | 0 / 59 | 5 / 59 | 59 / 59 |
| Arm 2A: AAPL Adjuvant Therapy (Part 2)Eligible participants will be randomized to receive adjuvant AAPL post surgery: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 12 months Of the 42 patients randomized to Arm 2A, only 37 patients received the AAPL treatment; 5 patients declined protocol treatment after part-2 randomization. Therefore, toxicities for Arm 2A were reported among the 37 patients who actually received AAPL treatment. | 0 / 37 | 4 / 37 | 30 / 37 |
| Arm 2B: Observation (Part 2)Eligible participants will be randomized to the observation arm post surgery. Of the 40 patients randomized to Arm 2B (observation), 38 remained on observation and 2 received non-protocol therapy. Therefore, the AE analysis for Arm 2B included the 38 patients on observation, excluding 2 patient receiving non-protocol therapy. | 0 / 38 | 0 / 38 | 28 / 38 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
2 studies on this page
Indexing hint: Randomized controlled trial · 2024
McKay et al. 2024Cancercited by 13
PMID 38161319DOI 10.1002/cncr.35170PUB-38161319
Indexing hint: Randomized controlled trial · 2021
McKay et al. 2021The Journal of urologycited by 73
PMID 33683939PMC9807004DOI 10.1097/ju.0000000000001702PUB-33683939
References listed at the registry that are not in PepBank. They link to PubMed.
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